FDA opens safety review of injectable RSV drugs approved for babies and toddlers

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

Covid Shots May Get FDA’s Strongest Warning

A CDC study released Thursday found that the 2024-2025 Covid vaccine was approximately 76 percent effective against emergency ...

FDA launches safety review of RSV infant drugs as RFK Jr. scrutinizes immunizations

The Food and Drug Administration has launched a safety review of two approved RSV drugs for infants, the latest immunizations ...

FDA changes heads of drug research and OTC drugs in latest shake-up

The U.S. Food and Drug Administration (FDA) has been rocked by recent changes to several leadership roles while it has ...

US FDA approves first drug under new fast-track review program

Dec 9 (Reuters) - The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program ...
The Manila Times

Ophirex Announces Business Update: Advances Toward Food and Drug Administration (FDA) Approval for Varespladib as Novel Oral Snakebite Treatment

Ophirex announced that varespladib, which is also being developed as an oral rescue treatment for snakebite envenomation in ...

US FDA qualifies first AI tool to help speed liver disease drug development

Dec 8 (Reuters) - The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help ...

FDA moves to expand sunscreen options, proposing ingredient used in Asia and Europe

The FDA has proposed adding bemotrizinol, a new sunscreen ingredient, to the U.S. approval list, which could expand consumer ...
STAT

FDA staff fear Tracy Beth Høeg will bring bias and instability to embattled drug center

WASHINGTON — In 2008, Tracy Beth Høeg, then a resident physician and ultramarathon runner, expressed dismay at vice ...
STAT

Pharmalittle: We’re reading about FDA staff fears, a Lilly weight loss drug and much more

In her nine months as scientific adviser to U.S. Food and Drug Administration Commissioner Marty Makary, Tracy Beth Høeg’s ...

FDA chief says Biden administration withheld data on heart risk from Covid vaccines

The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, FDA Commissioner ...