Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks ...

Pharmaceuticals announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application for EYLEA HD Injection 8 mg. The sBLA seeks ...

Treatments for COPD, psoriasis, and neuroendocrine tumors, as well as a next-generation COVID-19 vaccine are under review.

US food tech startup Perfect Day has been hit with a false marketing lawsuit for its FDA-approved, animal-free dairy whey ...

From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.

Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...

A novel drug for bloodstream infections, code-named VRP-034 and currently in the development stage pending final trials and ...

The Food and Drug Administration on Thursday cleared a core component of a brain implant made by Precision Neuroscience, a ...

U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies ...

Eli Lilly and Co., the maker of Zepbound and Mounjaro, announced a successful Phase 3 trial for a once-daily GLP-1 pill for ...

A Neuralink rival backed by a former collaborator of Elon Musk has just received FDA clearance for its brain implant.

The U.S. Food and Drug Administration has approved a core component of a neurotech brain implant system from a rival company ...