FDA Approvals Calendar
Found 25 Results
The treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation
November 26, 2018 12:00AM - November 26, 2018 12:00AM
Committee: Oncologic Drugs Advisory Committee and Pediatric Subcommittee
Indication: The treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without ...
Buprenorphine/ Samidorphan Application for FDA Approval
November 1, 2018 12:00AM - November 1, 2018 12:00AM
Committee: Psychopharmacologic Drugs Advisory Committee & Drug Safety and Risk Management Advisory Committee
Indication: Adjunctive treatment for Major Depression Disorder which is characterized by low mode, anhedonia, feelings of guilt and worthlessness, ...
Prucalopride (Motegrity) Receives Unanimous Vote for FDA Approval
October 18, 2018 12:00AM - October 18, 2018 12:00AM
Committee: Gastrointestinal Drug Advisory Committee
Indications: treatment of chronic idiopathic constipation (CIC) in adults
Question 1: Do the clinical trial data provide substantial evidence of effectiveness of Prucalopride for the ...