FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Organon's NEXPLANON receives U.S. FDA sNDA approval for extended duration of use up to five years, including data for use in women with varying BMIs.

Loyal’s application for drug approval is another step closer to potential approval through the FDA Center for Veterinary ...

Optum notable drugs nearing FDA approval include Anaphylm, Sotyktu, and insulin icodec with decisions expected early 2026.

Since the U.S. prescription launch of NARCAN® Nasal Spray in 2016, the medicine has been trusted as a safe, effective way to reverse opioid ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

The FDA accepted Besremi's application for essential thrombocythemia, supported by SURPASS-ET and EXCEED-ET trial results, with a review target date of August 30, 2026. Essential thrombocythemia is a ...

The firm said at the JP Morgan Healthcare Conference that it wants zorevunersen to be approved as a disease-modifying ...

The Texas Department of Public Safety has issued provisional licenses to nine new medical marijuana operators while existing ones have started opening new manufacturing and cultivating facilities.