FMI and Consumer Brands issue statement on HHS, FDA color additive announcement
HHS and FDA have announced plans to phase out all petroleum-based synthetic food dyes.
FDA
CHPA issues statement on HHS/FDA plans to phase out some synthetic dyes
The FDA and HHS have announced plans to phase out petroleum-based synthetic dyes from the national food supply and replace them with natural ingredients.
CHPA releases statement on FDA plans to end animal testing
“We look forward to working collaboratively with FDA and other stakeholders on this important scientific and regulatory paradigm shift,” says the CHPA.
AAM issues statement on FDA job cuts
“Today's staff reductions may undermine the Agency’s ability to approve and ensure the safety of lower-cost generic and biosimilar medicines.”
Massive layoffs at health agencies begin
The widespread layoffs and restructuring efforts have raised concerns about these agencies' future capacity to respond to public health crises, regulate critical medical products, and conduct essential research.
Industry groups issue statements on confirmation of Dr. Makary as FDA commissioner
The Senate confirmed Dr. Makary's nomination by a vote of 56-44.
FDA drug approvals dip 15.44% in 2024, but smaller pharma leads innovation
Despite the decrease, the landscape of pharmaceutical transformation still remains vibrant.
Compounding pharmacies keep copying Zepbound despite FDA ban
The FDA has yet to comment on how it will proceed. Eli Lilly could pursue legal action against compounding pharmacies.
RFK Jr moves to close FDA food safety loophole
The initiative seeks to revise the FDA’s “Generally Recognized as Safe” (GRAS) Final Rule.
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.