Akeso&#x27;s Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast Cancer

MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes Patients

MannKind Corporation announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Afrezza (insulin human) Inhalation ...

Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCC

Bicara Therapeutics announced that the FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for...

FDA Approves Boehringer Ingelheim's Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

The U.S. FDA has approved Boehringer Ingelheim's JASCAYD® (nerandomilast) tablets as the first new treatment option in over a decade for adults with I...

October 9, 2025

Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Tralesinidase Alfa for Sanfilippo Syndrome Type B

Spruce Biosciences received Breakthrough Therapy Designation from the FDA for tralesinidase alfa enzyme replacement therapy (TA-ERT) for the treatment...

October 7, 2025

Cellectar Biosciences Announces EMA Eligibility for Conditional Marketing Authorization of Iopofosine I 131 for Refractory Waldenstrom Macroglobulinemia

Cellectar Biosciences announced that the European Medicines Agency (EMA) has confirmed the eligibility to file for Conditional Marketing Authorization...

October 6, 2025

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for Cognitive Impairment Associated with Schizophrenia

Alto Neuroscience received FDA Fast Track designation for ALTO-101 for treating cognitive impairment associated with schizophrenia (CIAS). ALTO-101, a...

October 6, 2025

Vanda Pharmaceuticals Announces Collaborative Framework with FDA for Dispute Resolution

Vanda Pharmaceuticals and the FDA have agreed on a collaborative framework to resolve disputes regarding HETLIOZ® (tasimelteon) and tradipitant. The F...

October 2, 2025

AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450

AEON Biopharma announced that the FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 (prabotulinumtoxinA)...

October 2, 2025

Kedrion Biopharma Receives FDA Approval for QIVIGY for Primary Humoral Immunodeficiency

Kedrion Biopharma announced FDA approval for QIVIGY (Immune Globulin 10% IV) for treating adults with primary humoral immunodeficiency (PI). QIVIGY, a...

September 30, 2025

Biogen Receives Complete Response Letter from FDA for High Dose Nusinersen in Spinal Muscular Atrophy

Biogen announced that the FDA issued a Complete Response Letter (CRL) for its supplemental New Drug Application (sNDA) for a high dose regimen of nusi...

September 24, 2025

Noul Receives FDA Registration for Cervical Cancer Diagnostic Cartridge

Noul Co., Ltd. has secured FDA registration for its miLab™ Cartridge CER and SafeFix™ CER, essential components of its miLab™ CER cervical cancer diag...

September 24, 2025

Innovent's Mazdutide Approved in China for Glycemic Control in Type 2 Diabetes

Innovent Biologics announced that China's NMPA has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor a...

September 19, 2025

Biocon Biologics Receives FDA Approval for Denosumab Biosimilars Bosaya and Aukelso

Biocon Biologics Ltd. (BBL) announced that the U.S. FDA has approved Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq), biosimilars of Prolia® an...

September 18, 2025

Saol Therapeutics Receives FDA Complete Response Letter for SL1009 (DCA) for Pyruvate Dehydrogenase Complex Deficiency

Saol Therapeutics announced that the FDA issued a Complete Response Letter (CRL) for their New Drug Application (NDA) of SL1009 (Sodium Dichloroacetat...

September 9, 2025

Agios Pharmaceuticals Announces PDUFA Date Extension for PYRUKYND® in Thalassemia

Agios Pharmaceuticals announced a three-month extension to the FDA's Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Ap...

September 4, 2025

C4 Therapeutics' Partner Biogen Receives FDA IND Acceptance for IRAK4 Degrader BIIB142

C4 Therapeutics announced that its partner, Biogen, received FDA IND acceptance for BIIB142, an IRAK4 degrader. BIIB142 is intended for the treatment...

September 4, 2025

Olomorasib Receives FDA Breakthrough Therapy Designation for KRAS G12C-Mutant Lung Cancer

Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olomorasib, in combin...

September 4, 2025

FDA Accepts Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilars

Professor Sarfaraz K. Niazi secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars. This...

September 2, 2025

FDA Approves BILDYOS® and BILPREVDA®, Biosimilars to PROLIA and XGEVA

The US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to PROLIA and XGEVA, res...

September 2, 2025

Boehringer Ingelheim's HERNEXEOS® Approved in China for HER2-Mutant NSCLC

Boehringer Ingelheim announced the approval of HERNEXEOS® (zongertinib) by China's NMPA for treating adult patients with unresectable, locally advance...

September 1, 2025

Abbott's Navitor TAVI System Receives CE Mark for Expanded Aortic Stenosis Indication

Abbott announced that its Navitor transcatheter aortic valve implantation (TAVI) system received CE Mark approval in Europe for an expanded indication...

September 1, 2025

Vanda Pharmaceuticals' VGT-1849B Receives Orphan Drug Designation for Polycythemia Vera

Vanda Pharmaceuticals announced that the FDA granted Orphan Drug Designation to VGT-1849B, a selective JAK2 inhibitor for treating polycythemia vera (...

August 29, 2025

Teva Launches First Generic GLP-1 for Weight Loss: Liraglutide Injection

Teva Pharmaceuticals announced the FDA approval and US launch of its generic version of Saxenda® (liraglutide injection), the first generic glucagon-l...

August 29, 2025

Avenacy Launches Lidocaine Hydrochloride Injection in the U.S.

Avenacy, a specialty pharmaceutical company, announced the launch of its Lidocaine Hydrochloride Injection, USP, in the United States. This is Avenacy...

August 25, 2025

FDA Suspends License for Valneva's Chikungunya Vaccine IXCHIQ®

Valneva announced that the FDA has suspended the license for its chikungunya vaccine, IXCHIQ®, due to four new reports of serious adverse events (SAEs...

August 25, 2025

FDA Approves Wegovy® for the Treatment of MASH

Novo Nordisk announced that the FDA has approved Wegovy® (semaglutide 2.4 mg) for the treatment of noncirrhotic metabolic dysfunction-associated steat...

Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease

Labcorp announced the nationwide availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for Alzheimer's disea...

AstraZeneca Launches At-Home Delivery Service for FluMist Nasal Spray Vaccine

AstraZeneca has launched FluMist Home, a first-of-its-kind at-home delivery service for its FLUMIST® (Influenza Vaccine Live, Intranasal) nasal spray ...

FDA Approves Papzimeos for Recurrent Respiratory Papillomatosis

The FDA has granted full approval to Precigen's Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with Recurrent Respiratory Papillom...

Echosens and Novo Nordisk Partner to Improve MASH Diagnosis and Treatment

Echosens and Novo Nordisk are expanding their partnership to increase awareness and early diagnosis of metabolic dysfunction-associated steatohepatiti...

Trinity Biotech Receives Regulatory Approval for PreClara™ Preeclampsia Test

Trinity Biotech plc announced that its New York reference laboratory received regulatory approval from the New York State Department of Health (NYSDOH...

August 15, 2025

FDA Clears DeepSight's NeedleVue™ LC1 Ultrasound System

DeepSight Technology announced FDA 510(k) clearance for its NeedleVue™ LC1 Ultrasound System. This system, along with the company's NeedleVue™ and OnP...

August 14, 2025

Dyne Therapeutics' DYNE-251 Receives FDA Breakthrough Therapy Designation for Duchenne Muscular Dystrophy

Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-251 for treating Duchenne muscular dystrophy (DMD) amenable ...

August 5, 2025

Agios' PYRUKYND® (mitapivat) Approved for Thalassemia in Saudi Arabia

Agios Pharmaceuticals announced that the Saudi Food and Drug Authority (SFDA) has approved PYRUKYND® (mitapivat) for treating adult patients with non-...

August 5, 2025

BioCardia Announces FDA and PMDA Regulatory Timeline for CardiAMP® Cell Therapy and Helix™ Catheter

BioCardia, Inc. announced its anticipated timeline for seeking FDA and Japan PMDA approvals for its CardiAMP® Cell Therapy System and Helix™ Transendo...

August 4, 2025

AbbVie Seeks FDA Approval for Venetoclax and Acalabrutinib Combination in Untreated CLL

AbbVie submitted a supplemental New Drug Application (sNDA) to the FDA for a fixed-duration, all-oral combination of VENCLEXTA (venetoclax) and acalab...

July 30, 2025

Sanofi's SAR446523 Receives Orphan Drug Designation for Multiple Myeloma

Sanofi announced that the FDA granted orphan drug designation to SAR446523, a monoclonal antibody targeting GPRC5D, for the treatment of relapsed or r...

July 30, 2025

Positive CHMP Opinion for Deciphera's Vimseltinib in Treating Tenosynovial Giant Cell Tumor

Deciphera Pharmaceuticals and Ono Pharmaceutical announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) ...

July 29, 2025

Positive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment

BeOne Medicines announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recomme...

July 28, 2025

Krystal Biotech's VYJUVEK® Approved in Japan for Dystrophic Epidermolysis Bullosa

Krystal Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYJUVEK® (beremagene geperpavec-svdt) for treating dystr...

July 28, 2025

Shanton Pharma's SAP-001 Receives FDA Fast Track Designation for Refractory Gout

Shanton Pharma announced that the FDA granted Fast Track designation to its investigational new drug, SAP-001, for treating hyperuricemia in adult gou...

July 28, 2025

Blenrep Combinations Approved in Canada for Relapsed/Refractory Multiple Myeloma

Health Canada has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone, or with pomalidomide and dexamethasone, fo...

July 23, 2025

Protagonist Submits NDA for Icotrokinra, a Novel Oral Treatment for Plaque Psoriasis

Protagonist Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for icotrokinra, a first-in-class oral peptide for treati...

July 22, 2025

Shorla Oncology's SH-110 Receives FDA Orphan Drug Designation for Glioma

Shorla Oncology announced that the FDA granted orphan drug designation to SH-110, an oral liquid formulation of a drug to treat glioma, a rare brain c...

July 16, 2025

ProKidney Announces FDA Alignment on Accelerated Approval Pathway for Rilparencel

ProKidney announced FDA confirmation that the accelerated approval pathway for rilparencel, an autologous cellular therapy for chronic kidney disease ...

July 16, 2025

Vertex Pharmaceuticals Wins Innovation Award for JOURNAVX™, a Novel Non-Opioid Acute Pain Treatment

Vertex Pharmaceuticals announced that its non-opioid pain medication, JOURNAVX™ (suzetrigine), has been recognized as a groundbreaking healthcare tech...

Corcept Submits NDA for Relacorilant in Platinum-Resistant Ovarian Cancer

Corcept Therapeutics announced the submission of a New Drug Application (NDA) to the FDA for relacorilant, a selective cortisol modulator, in combinat...

Caranx Medical Receives FDA Clearance for AI-Powered Software Guiding Transcatheter Heart Valve Implantation

Caranx Medical announced FDA clearance for TAVIPILOT Soft, the world's first AI software for real-time intra-operative guidance of transcatheter aorti...

Sun Pharma Launches LEQSELVI™ (deuruxolitinib) for Severe Alopecia Areata in the U.S.

Sun Pharma announced the launch of LEQSELVI™ (deuruxolitinib) in the United States for the treatment of adults with severe alopecia areata. LEQSELVI ...

FDA Grants Fast Track Designation to Zenith's ZEN-3694 for NUT Carcinoma

Zenith Epigenetics announced that the FDA granted Fast Track designation to ZEN-3694, in combination with abemaciclib, for treating metastatic or unre...

FDA Rejects Ultragenyx's Gene Therapy for Sanfilippo Syndrome Due to Manufacturing Issues

Ultragenyx's investigational gene therapy, UX111, for Sanfilippo syndrome type A, was rejected by the FDA due to manufacturing concerns. The FDA's co...

EMA Lifts Restriction on Valneva's Chikungunya Vaccine IXCHIQ® for Elderly Patients

Valneva announced that the European Medicines Agency (EMA) has lifted the temporary restriction on using its single-dose chikungunya vaccine, IXCHIQ®,...

Zevra Therapeutics Announces Presentations on MIPLYFFA® (arimoclomol) at Niemann-Pick Disease Conference

Zevra Therapeutics announced that MIPLYFFA® (arimoclomol), the first FDA-approved treatment for Niemann-Pick disease type C (NPC), will be featured in...

FDA Approves KERENDIA® (finerenone) for Heart Failure with LVEF ≥40%

The U.S. Food and Drug Administration (FDA) has approved KERENDIA® (finerenone) to treat heart failure (HF) with left ventricular ejection fraction (L...

FDA Grants Orphan Drug Designation to Klotho Neurosciences' KLTO-202 for ALS

Klotho Neurosciences announced that the FDA granted Orphan Drug Designation to its KLTO-202 (s-KL-AAV.myo) for the treatment of Amyotrophic Lateral Sc...

July 10, 2025

Aktiia's Hilo Band: First Cuffless Blood Pressure Monitor Approved for OTC Use by FDA

Aktiia announced FDA 510(k) clearance for its cuffless blood pressure monitoring technology, marketed as the Hilo Band. This marks the first FDA clea...

July 10, 2025

FDA Approves Insightec's Exablate Neuro for Staged Bilateral Treatment of Parkinson's Disease

Insightec announced FDA approval of its Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson's ...

July 9, 2025

Novartis Receives Approval for First Malaria Medicine for Newborns and Young Infants

Novartis announced that Coartem® (artemether-lumefantrine) Baby, also known as Riamet® Baby, has received approval from Swissmedic as the first malari...

July 8, 2025

EmpNia Receives FDA Clearance for eMotus™ Respiratory Motion Management System

EmpNia Inc. announced FDA clearance for its eMotus™ system, a disposable sensor pad and software for managing respiratory motion in image-guided radia...

July 1, 2025

China Approves HUTCHMED's ORPATHYS® and TAGRISSO® Combination for Lung Cancer

HUTCHMED announced that the China National Medical Products Administration (NMPA) approved the combination of ORPATHYS® (savolitinib) and TAGRISSO® (o...

June 30, 2025

FDA Grants Priority Review to Syndax's Revuforj® (revumenib) for Relapsed/Refractory mNPM1 AML

Syndax Pharmaceuticals announced that the FDA granted Priority Review to its supplemental New Drug Application (sNDA) for Revuforj® (revumenib) to tre...

June 25, 2025

FDA Grants RMAT Designation to enGene's Detalimogene for High-Risk Bladder Cancer

enGene Holdings Inc. announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational therapy, det...

June 25, 2025

Dupixent Approved for Bullous Pemphigoid

The FDA has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), a chronic, debilitating, and rare skin disease. T...

Zemcelpro® Receives Positive CHMP Opinion for Blood Cancer Treatment

ExCellThera announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opin...

Madrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra) for MASH

Madrigal Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinio...

Relief Therapeutics' RLF-TD011 Denied QIDP Designation but Remains on Track for EB Treatment

Relief Therapeutics announced that its RLF-TD011, a hypochlorous acid solution for epidermolysis bullosa (EB), was not granted Qualified Infectious Di...

Ipsen's Cabometyx Receives Positive CHMP Opinion for Advanced Neuroendocrine Tumors

Ipsen announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Cabometyx (ca...

Dupixent Approved for Bullous Pemphigoid

The FDA has approved Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), a chronic, debilitating, rare skin disease. This ...

FDA Approval of Keytruda for Head and Neck Cancer Highlights Potential for CEL-SCI's Multikine in PD-L1 Negative Patients

The FDA's approval of Merck's Keytruda for PD-L1 positive head and neck squamous cell carcinoma (HNSCC) based on interim Phase 3 data, sets a preceden...

June 18, 2025

Dyne Therapeutics Receives FDA Breakthrough Therapy Designation for DYNE-101 in Myotonic Dystrophy Type 1

Dyne Therapeutics announced that the FDA granted Breakthrough Therapy Designation to DYNE-101 for treating myotonic dystrophy type 1 (DM1). This foll...

June 18, 2025

Neuspera Medical Receives FDA Approval for Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence

Neuspera Medical announced FDA approval of its integrated sacral neuromodulation (iSNM) system for treating urinary urge incontinence (UUI). This sys...

June 18, 2025

FDA Delays Sebetralstat NDA Decision Due to Resource Constraints

KalVista Pharmaceuticals announced that the FDA will not meet the June 17, 2025 PDUFA goal date for sebetralstat, an investigational oral on-demand tr...

June 16, 2025

FDA Approves IND Application for Myrio's PHOX2B PC-CAR T Therapy for Neuroblastoma

Myrio Therapeutics announced that the FDA approved its Investigational New Drug (IND) application for PHOX2B PC-CAR T, a chimeric antigen receptor (CA...

June 16, 2025

Amneal Receives FDA Approval for Prednisolone Acetate Ophthalmic Suspension

Amneal Pharmaceuticals announced FDA approval of its prednisolone acetate ophthalmic suspension 1%, a generic version of Pred Forte. This sterile, top...

June 13, 2025

Moderna's RSV Vaccine, mRESVIA, Receives FDA Approval for Expanded Use in Adults Aged 18-59

Moderna announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), its respiratory syncytial virus (RSV) vaccine, fo...

June 13, 2025

FDA Approves Roche's Susvimo for Diabetic Retinopathy

The US Food and Drug Administration (FDA) has approved Roche's Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR). Susv...

ENHERTU® Receives Time-Limited Reimbursement in Canada for Gastric Cancer

AstraZeneca and Daiichi Sankyo announced that Canada's Drug Agency (CDA) has issued a Time-Limited Reimbursement (TLR) recommendation for ENHERTU® (tr...

FDA Approves Arcutis' ZORYVE Topical Foam for Plaque Psoriasis

Arcutis Biotherapeutics announced FDA approval of ZORYVE (roflumilast) topical foam 0.3% for treating plaque psoriasis in adults and adolescents (12+)...

FDA Approves Nucala for COPD Expansion

The FDA approved GSK's Nucala (mepolizumab), an anti-IL-5 antibody, for the treatment of chronic obstructive pulmonary disease (COPD). This approval e...

FDA Approves Genentech's Susvimo for Diabetic Retinopathy

Genentech announced FDA approval of Susvimo (ranibizumab injection) 100 mg/mL for treating diabetic retinopathy (DR). Susvimo, delivered via a Port D...

FDA Approves Phraxis' EndoForce™ Connector for Dialysis Access

Phraxis Inc. announced FDA approval of its EndoForce™ Connector for Endovascular Venous Anastomosis, a medical device designed to simplify the creatio...

Akeso's Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast Cancer

Saptalis Pharmaceuticals Launches LIKMEZ®, First FDA-Approved Ready-to-Use Metronidazole Oral Suspension

Saptalis Pharmaceuticals announced the launch of LIKMEZ® (metronidazole) oral suspension, the first and only US FDA-approved ready-to-use oral liquid ...

May 21, 2025

Cingulate's CTx-1301 for ADHD: FDA Alignment on NDA Filing

Cingulate Inc. announced that it received positive feedback from the FDA regarding its pre-New Drug Application (NDA) meeting for CTx-1301, a novel on...

May 15, 2025

QurAlis Licenses Novel Mechanism for Fragile X Syndrome Treatment

QurAlis Corporation announced an exclusive license agreement with UMass Chan Medical School for a novel RNA-targeted mechanism to treat Fragile X synd...

May 15, 2025

Median Technologies Submits 510(k) Application for eyonis® LCS Lung Cancer Screening SaMD

Median Technologies announced the submission of a 510(k) application to the FDA for eyonis® LCS, an AI-powered software as a medical device (SaMD) for...

May 14, 2025

Soleno Therapeutics Presents VYKAT™ XR Data at ISPOR 2025 for Prader-Willi Syndrome

Soleno Therapeutics announced presentations at the ISPOR 2025 meeting featuring data on VYKAT™ XR (diazoxide choline) extended-release tablets for the...

May 14, 2025

Terumo Neuro Launches SOFIA™ 88 Neurovascular Support Catheter in the US

Terumo Neuro announced the US commercial availability of the SOFIA™ 88 Neurovascular Support Catheter. This large-bore catheter is designed for relia...

May 14, 2025

FDA Clears United Imaging's uAngio® AVIVA Interventional X-Ray System

United Imaging announced FDA clearance for its uAngio® AVIVA interventional X-ray system. This ceiling-mounted system features intelligent robotics, ...

May 13, 2025

InnoCare's Mesutoclax Receives Breakthrough Therapy Designation in China

InnoCare Pharma announced that its BCL2 inhibitor, Mesutoclax (ICP-248), received Breakthrough Therapy Designation from China's NMPA for treating rela...

May 12, 2025

FDA and CDC Recommend Pause in IXCHIQ® Use for Elderly Individuals

Valneva announced that the FDA and CDC recommend pausing the use of their chikungunya vaccine, IXCHIQ®, in elderly individuals due to reported serious...

May 12, 2025

Viridian Therapeutics' Veligrotug Receives FDA Breakthrough Therapy Designation for Thyroid Eye Disease

Viridian Therapeutics announced that the FDA granted Breakthrough Therapy Designation to veligrotug, its lead drug candidate for treating Thyroid Eye ...

May 8, 2025

FDA Grants Orphan Drug Designation to JR-446 for Mucopolysaccharidosis Type IIIB

The U.S. Food and Drug Administration (FDA) granted orphan drug designation to JR-446, a drug developed by MEDIPAL HOLDINGS CORPORATION and JCR Pharma...

May 8, 2025

EMA Suspends IXCHIQ® Chikungunya Vaccine for Elderly Due to Adverse Events

The European Medicines Agency (EMA) has temporarily suspended the use of Valneva's chikungunya vaccine, IXCHIQ®, in individuals over 65 due to reports...

May 8, 2025

July 2025

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Other Regulatory Approvals

November 3, 2025

Vizient Applauds FDA Actions to Accelerate Biosimilar Development and Lower Costs

October 31, 2025

FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) for Pulmonary Arterial Hypertension Based on Phase 3 ZENITH Study

October 27, 2025

FDA Approves Genentech's Gazyva for Lupus Nephritis Treatment

October 20, 2025

OS Therapies Receives FDA and MHRA Feedback on OST-HER2 for Metastatic Osteosarcoma

October 17, 2025

Civica to Launch Affordable Long-Acting Insulin Glargine in the US

October 16, 2025

Palisade Bio Receives Canadian Patent for PALI-2108 Composition

October 14, 2025

MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes Patients

October 14, 2025

Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCC

October 14, 2025

FDA Approves Boehringer Ingelheim's Jascayd (Nerandomilast) for Idiopathic Pulmonary Fibrosis

October 9, 2025

Spruce Biosciences Receives FDA Breakthrough Therapy Designation for Tralesinidase Alfa for Sanfilippo Syndrome Type B

October 7, 2025

Cellectar Biosciences Announces EMA Eligibility for Conditional Marketing Authorization of Iopofosine I 131 for Refractory Waldenstrom Macroglobulinemia

October 6, 2025

Alto Neuroscience Receives FDA Fast Track Designation for ALTO-101 for Cognitive Impairment Associated with Schizophrenia

October 6, 2025

Vanda Pharmaceuticals Announces Collaborative Framework with FDA for Dispute Resolution

October 2, 2025

AEON Biopharma Announces FDA BPD Type 2a Meeting for ABP-450

October 2, 2025

Kedrion Biopharma Receives FDA Approval for QIVIGY for Primary Humoral Immunodeficiency

September 30, 2025

Biogen Receives Complete Response Letter from FDA for High Dose Nusinersen in Spinal Muscular Atrophy

September 24, 2025

Noul Receives FDA Registration for Cervical Cancer Diagnostic Cartridge

September 24, 2025

Innovent's Mazdutide Approved in China for Glycemic Control in Type 2 Diabetes

September 19, 2025

Biocon Biologics Receives FDA Approval for Denosumab Biosimilars Bosaya and Aukelso

September 18, 2025

Saol Therapeutics Receives FDA Complete Response Letter for SL1009 (DCA) for Pyruvate Dehydrogenase Complex Deficiency

September 9, 2025

Agios Pharmaceuticals Announces PDUFA Date Extension for PYRUKYND® in Thalassemia

September 4, 2025

C4 Therapeutics' Partner Biogen Receives FDA IND Acceptance for IRAK4 Degrader BIIB142

September 4, 2025

Olomorasib Receives FDA Breakthrough Therapy Designation for KRAS G12C-Mutant Lung Cancer

September 4, 2025

FDA Accepts Waiver of Clinical Efficacy Studies for Monoclonal Antibody Biosimilars

September 2, 2025

FDA Approves BILDYOS® and BILPREVDA®, Biosimilars to PROLIA and XGEVA

September 2, 2025

Boehringer Ingelheim's HERNEXEOS® Approved in China for HER2-Mutant NSCLC

September 1, 2025

Abbott's Navitor TAVI System Receives CE Mark for Expanded Aortic Stenosis Indication

September 1, 2025

Vanda Pharmaceuticals' VGT-1849B Receives Orphan Drug Designation for Polycythemia Vera

August 29, 2025

Teva Launches First Generic GLP-1 for Weight Loss: Liraglutide Injection

August 29, 2025

Avenacy Launches Lidocaine Hydrochloride Injection in the U.S.

August 25, 2025

FDA Suspends License for Valneva's Chikungunya Vaccine IXCHIQ®

August 25, 2025

FDA Approves Wegovy® for the Treatment of MASH

August 18, 2025

Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease

August 18, 2025

AstraZeneca Launches At-Home Delivery Service for FluMist Nasal Spray Vaccine

August 18, 2025

FDA Approves Papzimeos for Recurrent Respiratory Papillomatosis

August 18, 2025

Echosens and Novo Nordisk Partner to Improve MASH Diagnosis and Treatment

August 18, 2025

Trinity Biotech Receives Regulatory Approval for PreClara™ Preeclampsia Test

August 15, 2025

FDA Clears DeepSight's NeedleVue™ LC1 Ultrasound System

August 14, 2025

Dyne Therapeutics' DYNE-251 Receives FDA Breakthrough Therapy Designation for Duchenne Muscular Dystrophy

August 5, 2025

Agios' PYRUKYND® (mitapivat) Approved for Thalassemia in Saudi Arabia

August 5, 2025

BioCardia Announces FDA and PMDA Regulatory Timeline for CardiAMP® Cell Therapy and Helix™ Catheter

August 4, 2025

AbbVie Seeks FDA Approval for Venetoclax and Acalabrutinib Combination in Untreated CLL

July 30, 2025

Sanofi's SAR446523 Receives Orphan Drug Designation for Multiple Myeloma

July 30, 2025

Positive CHMP Opinion for Deciphera's Vimseltinib in Treating Tenosynovial Giant Cell Tumor

July 29, 2025

Positive CHMP Opinion for TEVIMBRA® in Neoadjuvant/Adjuvant NSCLC Treatment

July 28, 2025

Krystal Biotech's VYJUVEK® Approved in Japan for Dystrophic Epidermolysis Bullosa

July 28, 2025

Shanton Pharma's SAP-001 Receives FDA Fast Track Designation for Refractory Gout

July 28, 2025

Blenrep Combinations Approved in Canada for Relapsed/Refractory Multiple Myeloma

July 23, 2025

Protagonist Submits NDA for Icotrokinra, a Novel Oral Treatment for Plaque Psoriasis

July 22, 2025

Shorla Oncology's SH-110 Receives FDA Orphan Drug Designation for Glioma

July 16, 2025

ProKidney Announces FDA Alignment on Accelerated Approval Pathway for Rilparencel

July 16, 2025

Vertex Pharmaceuticals Wins Innovation Award for JOURNAVX™, a Novel Non-Opioid Acute Pain Treatment

July 15, 2025

Corcept Submits NDA for Relacorilant in Platinum-Resistant Ovarian Cancer

July 15, 2025

Caranx Medical Receives FDA Clearance for AI-Powered Software Guiding Transcatheter Heart Valve Implantation

July 15, 2025

Sun Pharma Launches LEQSELVI™ (deuruxolitinib) for Severe Alopecia Areata in the U.S.

July 15, 2025

FDA Grants Fast Track Designation to Zenith's ZEN-3694 for NUT Carcinoma

July 14, 2025

FDA Rejects Ultragenyx's Gene Therapy for Sanfilippo Syndrome Due to Manufacturing Issues

July 14, 2025

EMA Lifts Restriction on Valneva's Chikungunya Vaccine IXCHIQ® for Elderly Patients

July 14, 2025

Zevra Therapeutics Announces Presentations on MIPLYFFA® (arimoclomol) at Niemann-Pick Disease Conference

July 14, 2025

FDA Approves KERENDIA® (finerenone) for Heart Failure with LVEF ≥40%

July 14, 2025

FDA Grants Orphan Drug Designation to Klotho Neurosciences' KLTO-202 for ALS

July 10, 2025

Aktiia's Hilo Band: First Cuffless Blood Pressure Monitor Approved for OTC Use by FDA

July 10, 2025

FDA Approves Insightec's Exablate Neuro for Staged Bilateral Treatment of Parkinson's Disease

July 9, 2025

Novartis Receives Approval for First Malaria Medicine for Newborns and Young Infants

July 8, 2025

EmpNia Receives FDA Clearance for eMotus™ Respiratory Motion Management System

July 1, 2025

China Approves HUTCHMED's ORPATHYS® and TAGRISSO® Combination for Lung Cancer

June 30, 2025

FDA Grants Priority Review to Syndax's Revuforj® (revumenib) for Relapsed/Refractory mNPM1 AML

June 25, 2025

FDA Grants RMAT Designation to enGene's Detalimogene for High-Risk Bladder Cancer

June 25, 2025

Dupixent Approved for Bullous Pemphigoid

June 20, 2025

Zemcelpro® Receives Positive CHMP Opinion for Blood Cancer Treatment

June 20, 2025

Madrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra) for MASH

June 20, 2025

Relief Therapeutics' RLF-TD011 Denied QIDP Designation but Remains on Track for EB Treatment

June 20, 2025

Ipsen's Cabometyx Receives Positive CHMP Opinion for Advanced Neuroendocrine Tumors

June 20, 2025

Dupixent Approved for Bullous Pemphigoid

June 20, 2025

FDA Approval of Keytruda for Head and Neck Cancer Highlights Potential for CEL-SCI's Multikine in PD-L1 Negative Patients

June 18, 2025

Dyne Therapeutics Receives FDA Breakthrough Therapy Designation for DYNE-101 in Myotonic Dystrophy Type 1

June 18, 2025

Neuspera Medical Receives FDA Approval for Integrated Sacral Neuromodulation (iSNM) System for Urinary Urge Incontinence

June 18, 2025

FDA Delays Sebetralstat NDA Decision Due to Resource Constraints

June 16, 2025

FDA Approves IND Application for Myrio's PHOX2B PC-CAR T Therapy for Neuroblastoma

June 16, 2025

Amneal Receives FDA Approval for Prednisolone Acetate Ophthalmic Suspension

June 13, 2025

Moderna's RSV Vaccine, mRESVIA, Receives FDA Approval for Expanded Use in Adults Aged 18-59

June 13, 2025

FDA Approves Roche's Susvimo for Diabetic Retinopathy

May 23, 2025

ENHERTU® Receives Time-Limited Reimbursement in Canada for Gastric Cancer

May 23, 2025

FDA Approves Arcutis' ZORYVE Topical Foam for Plaque Psoriasis

May 23, 2025

FDA Approves Nucala for COPD Expansion

May 23, 2025

FDA Approves Genentech's Susvimo for Diabetic Retinopathy

May 23, 2025

FDA Approves Phraxis' EndoForce™ Connector for Dialysis Access

May 23, 2025

Saptalis Pharmaceuticals Launches LIKMEZ®, First FDA-Approved Ready-to-Use Metronidazole Oral Suspension

May 21, 2025

Cingulate's CTx-1301 for ADHD: FDA Alignment on NDA Filing

May 15, 2025

QurAlis Licenses Novel Mechanism for Fragile X Syndrome Treatment

May 15, 2025

Median Technologies Submits 510(k) Application for eyonis® LCS Lung Cancer Screening SaMD

May 14, 2025

Soleno Therapeutics Presents VYKAT™ XR Data at ISPOR 2025 for Prader-Willi Syndrome

May 14, 2025

Terumo Neuro Launches SOFIA™ 88 Neurovascular Support Catheter in the US

May 14, 2025

FDA Clears United Imaging's uAngio® AVIVA Interventional X-Ray System

May 13, 2025

InnoCare's Mesutoclax Receives Breakthrough Therapy Designation in China

May 12, 2025

FDA and CDC Recommend Pause in IXCHIQ® Use for Elderly Individuals

May 12, 2025

Viridian Therapeutics' Veligrotug Receives FDA Breakthrough Therapy Designation for Thyroid Eye Disease

May 8, 2025

FDA Grants Orphan Drug Designation to JR-446 for Mucopolysaccharidosis Type IIIB

May 8, 2025

EMA Suspends IXCHIQ® Chikungunya Vaccine for Elderly Due to Adverse Events

May 8, 2025

Latest Regulatory Approvals

Akeso's Ivonescimab Receives Breakthrough Therapy Designation in China for Triple-Negative Breast Cancer

Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, has been granted Breakthrough Therapy Designation (BTD) by China's National Medical Products Adm...

November 3, 2025

Vizient Applauds FDA Actions to Accelerate Biosimilar Development and Lower Costs

Vizient commends the FDA for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater cla...

October 31, 2025

FDA Approves Updated Indication for WINREVAIR™ (sotatercept-csrk) for Pulmonary Arterial Hypertension Based on Phase 3 ZENITH Study

Merck announced that the FDA has approved an update to the U.S. product label for WINREVAIR™ (sotatercept-csrk) based on the Phase 3 ZENITH trial. The...

October 27, 2025

FDA Approves Genentech's Gazyva for Lupus Nephritis Treatment

The FDA has approved Genentech's Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis (LN) receiving standard therapy. The ap...

October 20, 2025

OS Therapies Receives FDA and MHRA Feedback on OST-HER2 for Metastatic Osteosarcoma

OS Therapies Inc. announced that the FDA granted a Type C meeting to discuss clinical efficacy data endpoints for a BLA under the Accelerated Approval...

October 17, 2025

Civica to Launch Affordable Long-Acting Insulin Glargine in the US

Non-profit pharmaceutical company Civica is set to launch a long-acting insulin, insulin glargine-yfgn, in pre-filled pens at the lowest list price in...

October 16, 2025

Palisade Bio Receives Canadian Patent for PALI-2108 Composition

Palisade Bio announced that the Canadian Intellectual Property Office has granted patent number 3,174,137 for the composition of PALI-2108, its orally...

MannKind Corporation announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Afrezza (insulin human) Inhalation ...

MannKind Announces FDA Acceptance of sBLA for Afrezza in Pediatric Diabetes Patients

Bicara Therapeutics announced that the FDA has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for...

Bicara Therapeutics Receives FDA Breakthrough Therapy Designation for Ficerafusp Alfa in 1L HPV-Negative R/M HNSCC