A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging ...

The US Food and Drug Administration intends to put a “black box” warning on Covid-19 vaccines, according to two people familiar with the agency’s plans.

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

Vinay Prasad, the head of the US FDA's Center for Biologics Evaluations and Research which oversees vaccines, said that ...

The U.S. Food and Drug Administration has approved an expanded indication for MED-EL (Medical Electronics) cochlear implants ...

The U.S. Food and Drug Administration has approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of ...

In a closely watched case, the U.S. solicitor general urged the Supreme Court to review a controversy over so-called skinny ...

Pro-life organizations are raising concerns about the FDA's delay in reviewing the abortion drug mifepristone. Learn more now.

Federal health officials are reviewing the safety of two injectable drugs used to protect babies and toddlers from the RSV virus.

Nov 21 (Reuters) - The U.S. Food and Drug Administration's new head of the drug evaluation department, Richard Pazdur, has raised concerns about the legality and pace of new initiatives to expedite ...