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FDA Grants Priority Review to Regeneron’s Eylea for Macular Edema Following Retinal Vein Occlusion
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 ...
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