The US Food and Drug Administration (FDA) has granted 510 (k) clearance to Surgical Theater's next-generation platform, ...

The approval is supported by a combination of current clinical data and model-informed drug development techniques.

The U.S. Food and Drug Administration on Friday approved labeling changes for Johnson & Johnson and its partner Legend ...

BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation ...

ReviR Therapeutics, a biotech company focused on developing novel treatments for neurogenetic diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug ...

Federal regulators are proposing to remove another artificial dye from the U.S. food supply — Orange B, a synthetic color that hasn’t been used in the U.S. for decades.

The FDA approved generic mifepristone from Evita Solutions, and Sen. Josh Hawley blasted the agency for regulatory failure ...

FDA approves Bravecto Quantum (fluralaner), the first annual injection against fleas and ticks in dogs, offering 12 months of ...

The Food and Drug Administration (FDA) approved a new generic version of mifepristone on Tuesday. Weeks after confirming a ...

The Food and Drug Administration (FDA) approved the drug even as the administration is currently investigating the abortion ...

Food recalls and disease outbreaks are happening at a rapid clip. Here’s a concise rundown of major new U.S. food ...

The FDA quietly approved a new generic version of mifepristone in a letter Tuesday, despite promising to evaluate the drug's ...