Category - New Drug Applications
Bayer Submits New Drug Application to U.S. FDA for Elinzanetant for the Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause
Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain
U.S. FDA Grants Tentative Approval of Yutrepia (treprostinil) Inhalation Powder for Patients with Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)
LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia
Lykos Therapeutics Announces Complete Response Letter for Midomafetamine Capsules for PTSD
Telix Submits NDA for TLX101-CDx (Pixclara) Brain Cancer Imaging Agent
FDA Grants Priority Review to SpringWorks Therapeutics’ New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN