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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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...

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

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...

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