Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market
The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...
STAT11h
Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
STAT55m
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
JD Supra13h
FDA’s Fresh Take on Use of “Healthy” in Food Labeling
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition ...
JD Supra15h
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
BioPharma Dive16h
FDA adds warning to RSV shots from GSK, Pfizer
Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.
Pharma giant seeks to join lawsuit against FDA over weight loss drugs
Eli Lilly is seeking to end a lawsuit filed by a pharmacy trade group against the Food and Drug Administration (FDA) by ...
FDA's Food Safety Inspections Struggle Amid Staffing Shortfall
The FDA has failed to meet its mandated targets for domestic and foreign food safety inspections since fiscal 2018, the US ...
Afro20h
FDA updates the definition of ‘healthy’ foods
New FDA rules for 'healthy' food labels aim to align with federal dietary guidelines. Changes include limits on added sugars and sodium, and prioritize whole foods.
FDA approves new drug for advanced Parkinson’s Disease
Thousands of Americans are diagnosed every year with Parkinson’s Disease. It’s a movement disorder that affects the central ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...