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 ...
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Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
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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 ...
Rigel Announces R289 Granted Orphan Drug Designation by the FDA for MDS
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and ...
Rigel Pharmaceuticals Gets FDA Orphan-Drug Designation for R289
Rigel Pharmaceuticals on Thursday said the U.S. Food and Drug Administration granted orphan-drug designation to its proposed R289 treatment for myelodysplastic syndromes, a group of rare blood cancers ...
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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 ...
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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 ...
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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 ...
PureTech Drug Gets FDA Fast-Track Designation for Leukemia
The biotherapeutics company said the treatment, LYT-200, is being evaluated in two ongoing clinical trials. It was previously granted orphan drug designation for the treatment of acute myeloid ...
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 ...