U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

If you’re concerned about gardenia (genipin) blue and other naturally derived dyes altering the taste of your favorite food ...

Healthcare technology company Aktiia has received FDA 510(k) clearance for its over-the-counter cuffless blood pressure ...

New and disturbing concerns about fake GLP-1 drugs are cited in a letter sent to the FDA by Tennessee officials, including ...

Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Expr ...

Thermo Fisher’s NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi announced that the US FDA approved Dupixent® (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP).

Merck & Co., Inc. (NYSE: MRK) is one of the 10 Best Value Stocks to Buy According to Billionaires. The company announced that the US FDA approved ENFLONSIA™ (clesrovimab-cfor) for the prevention ...

FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad ...