Page 43 - Priority Review News Today

The FDA has granted priority review to the application for enzalutamide as a treatment for nmCSPC with BCR.

/PRNewswire/ -- Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food...

This follows ongoing dialogue with the U.S. FDA regarding the palovarotene NDA review, initiated in May 2021 Paris , Friday 13 August, 2021 - Ipsen today...

TARRYTOWN - Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration has approved Veopoz for the treatment of adult and pediatric patients 1 year of age and older with...

The FDA approved  Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Veopoz (pozelimab-bbfg) for adult and pediatric patients one year of age and older with CHAPLE disease, known as CD55-deficient 

FDA approves Abrysvo for immunization at 32 through 36 weeks gestational age of pregnancy to prevent lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age.

/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Abrysvo (Respiratory Syncytial Virus Vaccine), the first vaccine approved for use in...

A kidney disease drug with a ‘durable and clinically meaningful impact on kidney function’ has been granted priority review by the US Food and Drug Administration (FDA).

18.08.2023 - CHAPLE is an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms Approval represents 10th FDA-approved medicine invented by Regeneron With the approval of Veopoz, the ...

Based on results from a trial of repotrectinib in patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer, the FDA accepted the New Drug Application and set a Prescription Drug User Fee Act goal date of November 27, 2023.