Fda Drug Approval Calendar 2025. Drug Hunter Articles Archives The FDA has granted this application priority review, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025 supplemental New Drug Application (sNDA) Catalyst Date: March 23, 2025: Catalyst: PDUFA Date: Announcement: Read More: Website: Click Here: Mar 26
US FDA medical device approval chart Emergo from www.slideshare.net
See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks. AstraZeneca: EU Approves Imfinzi As First And Only Immunotherapy For LS - Small Cell Lung Cancer March 17, 2025 03:43 ET British drug major AstraZeneca Plc (AZN, AZN.L) announced Monday that its Imfinzi (durvalumab) has been approved in the European Union as first and only immunotherapy for limited-stage small cell lung cancer or LS-SCLC.
US FDA medical device approval chart Emergo
In June 2023, Leqembi (lecanemab) became the first fully FDA-approved medication of its kind of Alzheimer's disease Streamline your research and quickly compare the relative timing of competing catalysts. It's thought to work by targeting beta-amyloid plaques to slow the progression of the disease
Calendar 2025 Customized Finest Ultimate Prime Calendar 2025 Month Of February Modern Present. Upcoming PDUFA Dates, Study Results, Data Presentations, Top-Line Results, and more for biotechnology and pharmaceutical stocks. APPROVED: 2.21.2025: Ctexli (chenodiol) Cerebrotendinous xanthomatosis: Mirum Therapeutics: APPROVED: 2.28.2025 Mirdametinib: Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) Springworks Therapeutics: APPROVED: 3.6.2025: Encelto (revakinagene taroretcel-lwey) Macular telangiectasia type 2 (MacTel) Neurotech.
FDA Calendar FDA Tracker. If approved, neffy 1 mg is expected to be available by the end of May 2025 Streamline your research and quickly compare the relative timing of competing catalysts.