Category - New Drug Applications
FDA Grants Priority Review for Sanofi’s Dengue Vaccine Candidate
FDA Advisory Committee Recommends Approval of Shire’s Prucalopride (SHP555) for Chronic Idiopathic Constipation
FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
U.S. FDA Accepts Karyopharm’s New Drug Application for Selinexor and Grants Priority Review
Shield Therapeutics Announces Submission of a New Drug Application (NDA) for Feraccru for the treatment of Iron Deficiency