Category - New Drug Applications
Aldeyra Therapeutics Announces Achievement of Statistical Significance for Primary Endpoint and All Secondary Endpoints in Phase 3 INVIGORATE‑2 Trial of Reproxalap in Allergic Conjunctivitis
GSK Announces Extension of FDA Review Period for Momelotinib
ARS Pharmaceuticals Announces PDUFA Date Extension for neffy® (epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
Geron Announces Submission of New Drug Application to FDA for First-in-Class Telomerase Inhibitor Imetelstat
Aldeyra Therapeutics Provides Regulatory Update on ADX-2191
F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections
UCB Provides Update on U.S. FDA Review of the Biologics License Application for Bimekizumab
FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec