OX124 is based on Orexo´s world-class drug delivery platform amorphOX® and is designed to reverse...
Category - New Drug Applications
FDA Accepts Defender Pharmaceuticals’ New Drug Application for...
ST. LOUIS, MO—(BUSINESS WIRE)—September Sep. 26, 23—Defender Pharmaceuticals, Inc. (the...
Abeona Therapeutics Submits Biologics License Application to U.S. FDA Seeking Priority Review and Approval of EB-101 for the Treatment of Patients with Recessive Dystrophic Epidermolysis Bullosa
Basilea Announces FDA Acceptance of New Drug Application for Antibiotic Ceftobiprole
Alpha Cognition Announces Submission of New Drug Application to the FDA for ALPHA-1062 for Mild-to-Moderate Alzheimer’s Disease
FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility
Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole
Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese