- 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
- Mallinckrodt Confirms Receipt of Stannsoporfin Complete Response Letter
- Allergan Receives Complete Response Letter from the U.S. Food and Drug Administration for Ulipristal Acetate New Drug Application
- Evoke Pharma’s Gimoti NDA Accepted for FDA Review
- Ortho Dermatologics Resubmits U.S. New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion
- 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
- Complete Response Letter Issued for Remoxy
- FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of Multiple Sclerosis