New Drug Applications Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application for Vonoprazan 8 months ago
New Drug Applications FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition 8 months ago
New Drug Applications X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome 8 months ago
New Drug Applications Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD 8 months ago
New Drug Applications Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) Date 8 months ago
New Drug Applications Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG) 8 months ago
New Drug Applications Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review 8 months ago
New Drug Applications Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis 8 months ago
New Drug Applications FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study 8 months ago