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...
August 18, 2025
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...
August 18, 2025
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 ...
August 18, 2025
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...
August 18, 2025
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...
August 18, 2025
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...
July 15, 2025
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...
July 15, 2025
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...
July 15, 2025
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 ...
July 15, 2025
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...
July 14, 2025
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...
July 14, 2025
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®,...
July 14, 2025
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...
July 14, 2025
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...
July 14, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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 ...
June 20, 2025
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...
May 23, 2025
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...
May 23, 2025
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+)...
May 23, 2025
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...
May 23, 2025
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...
May 23, 2025
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...
May 23, 2025
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
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...
May 7, 2025
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...
May 2, 2025
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...
May 1, 2025
July 2025
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
June 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...
July 15, 2025
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...
July 15, 2025
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...
July 15, 2025
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 ...
July 15, 2025
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...
July 14, 2025
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...
July 14, 2025
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®,...
July 14, 2025
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...
July 14, 2025
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...
July 14, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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...
June 20, 2025
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 ...
June 20, 2025
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
May 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...
May 23, 2025
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...
May 23, 2025
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+)...
May 23, 2025
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...
May 23, 2025
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...
May 23, 2025
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...
May 23, 2025
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 ...
