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 ...

FDA launches safety review of two RSV drugs for infants as Kennedy 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

The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten ...
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 ...

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 ...

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

The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a ...
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 ...

FDA approves first new antibiotics to treat gonorrhea in decades, with hope to combat drug resistance

For the first time in decades, the US Food and Drug Administration has signed off on new antibiotics to fight gonorrhea. The approvals come at a critical moment: The sexually transmitted infection is ...

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

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...
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 ...