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September 18, 2025

Roche to Acquire 89bio for MASH Therapy Development

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Publication Reports

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 (...

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...

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...

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...

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...

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...

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 ...

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-...

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...

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...

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...

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) ...

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...

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...

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...

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...

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...

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...

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 ...

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...

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...

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 ...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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 ...

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...

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...

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...

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...

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...

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, ...

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...

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...

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 ...

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...

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...

Adcentrx Therapeutics' ADRX-0706 Receives Fast Track Designation for Advanced Cervical Cancer

Adcentrx Therapeutics announced that the FDA granted Fast Track designation to its lead program, ADRX-0706, a Nectin-4 ADC, for treating locally advan...

FDA Accepts NDA for Oral Semaglutide 25mg for Obesity

Novo Nordisk announced that the FDA accepted its New Drug Application (NDA) for a 25 mg oral formulation of Wegovy (semaglutide) for chronic weight ma...

FDA Approves Atzumi™ for Acute Migraine Treatment

Satsuma Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Atzumi™ (dihydroergotamine (DHE)) nasal powder for the...