- Novartis Announces FDA Filing Acceptance and Priority Review of Brolucizumab (RTH258) for Patients with Wet AMD
- Cosmo Pharmaceuticals Announces Submission of Remimazolam NDA to FDA
- Zogenix Receives Refusal to File Letter from U.S. Food and Drug Administration for Fintepla New Drug Application
- Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Biologics License Application to U.S. FDA
- Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US
- Evoke Pharma Receives Complete Response Letter and Recommendations to Address Deficiencies from FDA for Gimoti NDA
- Celgene Submits Application to FDA for Ozanimod for the Treatment of Relapsing Forms of Multiple Sclerosis
- FDA Issues Complete Response Letter for Zynquista (sotagliflozin)
- Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
- Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
- Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia
- Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
- TB Medicine Pretomanid Enters Regulatory Review Process in the United States
- Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam for the Treatment of Moderate-to-Severe Acne
- U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis