RFK Jr moves to close FDA food safety loophole
The initiative seeks to revise the FDA’s “Generally Recognized as Safe” (GRAS) Final Rule.
FDA
Novo Nordisk: FDA confirms end of Wegovy and Ozempic shortage
Novo Nordisk has increased manufacturing, running production facilities 24/7 to ensure steady shipments to wholesalers.
Head of food division at FDA resigns, citing numerous job cuts
Jones pointed to the layoffs of 89 staffers in the food division, cuts he called “indiscriminate.”
FDA approves Journavx for moderate to severe acute pain
Journavx is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years.
FDA approves BridgeBio Pharma's new heart drug
BridgeBio Pharma has received FDA approval for a new drug for a rare heart disease after very promising trials.
J & J seeks FDA nod for groundbreaking UC therapy
Johnson & Johnson has submitted an FDA application for the first subcutaneous IL-23 inhibitor for ulcerative colitis. This drug could offer patients a groundbreaking at-home treatment option.
FDA proposes ending use of decongestant found in many cold, allergy medicines
Currently, oral phenylephrine is widely used as a nasal decongestant active ingredient in many O-T-C monograph drug products.