Category - New Drug Applications
Biden Officials Stave Off Sticker Shock on Medicare Drug Premiums
F.D.A. Approves a New Antipsychotic Drug
Orexo Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Overdose
FDA Accepts Defender Pharmaceuticals’ New Drug Application for Intranasal Scopolamine Gel
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