The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined ...

July 10 (Reuters) - The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug ...

Sanofi has scored FDA approval for its subcutaneous version of Sarclisa, giving the multiple myeloma treatment a potential ...

Last year, the FDA started telling the public why it rejects new drugs. Now a pharmaceutical company says that transparency ...

July 10 (Reuters) - Elevar Therapeutics said on Friday that the U.S. FDA declined to approve its drug combination for a type ...

The third time is not the charm for Hengrui Pharma and Elevar Therapeutics’ star-crossed combination of camrelizumab and ...

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to ...

Documents reviewing the research on peptides note lack of good evidence of efficacy or safety. Yet an FDA panel will consider ...

The FDA says trace amounts of metals found in tampons, including arsenic and lead, are too low to pose a health risk.

Over 2.5 million bottles of prednisolone acetate eye drops have been recalled nationwide. The FDA warns that the eye drops were recalled due to the “presence of a foreign substance.” If your ...

The FDA is reviewing which compounded peptides will be permitted for production by specialized pharmacies, threatening consumer access.