Category - New Drug Applications
PTC Therapeutics Receives Formal Dispute Resolution Request Decision from the FDA’s Office of New Drugs
Catalyst Pharmaceuticals Announces Plans to Resubmit New Drug Application for Firdapse
U.S. FDA Files New Drug Application Under Priority Review for Migalastat for Treatment of Fabry Disease
Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros
FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation
Ortho Dermatologics Announces U.S. FDA Filing Acceptance for Jemdel Plaque Psoriasis Treatment
60° Pharmaceuticals (60P) Receives Priority Review Designation For Malaria Drug
SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox