- FDA Advisory Committee Recommends Approval of Dsuvia for the Treatment of Moderate-to-Severe Acute Pain
- Trevena Announces Oliceridine FDA Advisory Committee Meeting Outcome
- Bausch Health’s Bryhali (halobetasol propionate) Lotion, 0.01%, Receives Tentative FDA Approval For Plaque Psoriasis In Adults
- Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS)
- FDA Issues a Complete Response Letter to Acacia Pharma for Barhemsys
- 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
- Intra-Cellular Therapies Completes Submission of New Drug Application for Lumateperone for Treatment of Schizophrenia
- Neurelis Files New Drug Application for Valtoco (diazepam nasal spray), an Investigational Treatment for Pediatric, Adolescent and Adult Epilepsy Patients
- Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Erdafitinib for the Treatment of Metastatic Urothelial Cancer
- Ardelyx Submits New Drug Application for Tenapanor for IBS-C
- Acorda Announces FDA Extends Inbrija NDA Review Period
- Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression
- FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
- Akcea and Ionis Receive Complete Response Letter for Waylivra from FDA