Category - 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
FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study
UCB Provides Update on U.S. Regulatory Review of Bimekizumab
Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
FDA Accepts Submission to Add PH-ILD to Yutrepia™ Label
SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA
Vyluma Announces FDA Acceptance of New Drug Application For NVK002, Its Novel Investigational Treatment For Pediatric Myopia
Capivasertib in Combination with Faslodex Granted Priority Review in the US for Patients with Advanced HR-Positive Breast Cancer