Category - New Drug Applications
Motif Bio Announces FDA Acceptance of New Drug Application With Priority Review for Iclaprim for Treatment of Acute Bacterial Skin and Skin Structure Infections
FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters
FDA Advisory Committee Recommends Approval of Paratek’s Omadacycline
Evoke Pharma’s Gimoti NDA Accepted for FDA Review
Complete Response Letter Issued for Remoxy
Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA
FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis
INSYS Therapeutics Receives Complete Response Letter from FDA for Buprenorphine NDA