Category - New Drug Applications
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS
Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application for Vonoprazan
Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS
FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition
X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome
Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD
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