At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 ...

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” ...

After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with ...

The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug ...

Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease ...

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

On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...

After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and ...

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

Novavax Inc. is no stranger to delays. The Gaithersburg company ... principal deputy commissioner for the FDA, paused the review of Novavax’s product in “a highly unusual step” against ...

When detox timing is a concern, the TestClear Powdered Urine Kit provides a guaranteed way to pass a urine drug test. Unlike ...