The U.S. Food and Drug Administration greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Omeros, MannKind-United Therapeutics, and Revance Therapeutics were issued Complete Response Letters from the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration agreed to place Regeneron Pharmaceuticals Inc.’s Biologics License Application (BLA) for the Covid-19 drug REGEN-COV under priority review with a target action date of April 13, 2022.
The U.S. Food and Drug Administration accepted for review a Biologics License Application (BLA) for the anti-PD-1 antibody tislelizumab as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic therapy.
The U.S. Food and Drug Administration granted the Pfizer-BioNTech Covid-19 vaccine Comirnaty full approval.
The U.S. Food and Drug Administration rejected Sesen Bio’s lead candidate Viceneum (oportuzumab monatox-qqrs) as a treatment for BCG-unresponsive non-muscle invasive bladder cancer.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Henderson, Nev.-based Spectrum Pharmaceuticals.
The U.S. Food and Drug Administration approved Viatris and Biocon Biologics’ Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product, which is indicated to control high blood sugar in adults with Type 2 diabetes as well as adults and pediatric patients with Type 1 diabetes.
The U.S. Food and Drug Administration issued Incyte Corporation with a Complete Response Letter (CRL) over the company’s Biologics License Application (BLA) for retifanlimab for anal cancer.
Ocugen had to change the Pennsylvania-based eye disease company’s application for the Covid-19 vaccine Covaxin from an Emergency Use Authorization to a full Biologics License Application (BLA) approval.
