Category - New Drug Applications
F2G Announces FDA Filing Acceptance Of New Drug Application For Olorofim For The Treatment Of Invasive Fungal Infections
Cytokinetics Announces Outcome of FDA Advisory Committee Vote On Omecamtiv Mecarbil
Eyenovia Announces FDA Acceptance of New Drug Application for MydCombi™ for In-Office Pupil Dilation
Galera Submits New Drug Application for Avasopasem for Severe Oral Mucositis
Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
FDA Accepts Braeburn’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva