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US FDA
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- 1
Olympus has received a warning letter from the US Food and Drug Administration, according to Japanese news reports. The disclosure came as the company's shares were heavily sold the previous day, and investors are now weighing how the regulatory action will affect the stock in the current session. Market commentary sites are discussing the impact of the sell-off on trading today.
- 2FDA warns of salmonella outbreak linked to recalled Publix oysters▼FDA issues advisory about a salmonella outbreak and oysters recalled from Publix
The US Food and Drug Administration has issued an advisory about a salmonella outbreak, prompting a recall of oysters sold at Publix stores. Consumers are being urged not to eat the affected oysters and to check whether products they bought are included in the recall. Health officials are monitoring the outbreak as more details emerge.
- 3AMA Sets Out Framework for FDA Oversight of Medical Generative AI▼AMA Outlines Path Forward for FDA Oversight of Generative AI in Medicine
The American Medical Association has published recommendations for how the FDA should regulate generative artificial intelligence tools used in medicine. The proposal addresses oversight of AI systems that assist clinicians with diagnosis, documentation and treatment decisions, aiming to balance innovation with patient safety as adoption of such tools accelerates across US healthcare.
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UK-based food tech company Better Dairy has self-affirmed that its lactopontin, a dairy protein produced without animals, meets GRAS (Generally Recognized as Safe) status under US food regulations. The move allows the company to market the ingredient in American food products without a pre-market review by the FDA. Industry observers see it as a step toward bringing precision-fermented dairy proteins to mainstream food manufacturing.
- 5Gottlieb Discusses FDA Rare Disease Framework and Measles Outbreak▼Dr. Scott Gottlieb on FDA's Rare Disease Framework, measles outbreak latest and rise of peptides
Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, spoke publicly about the agency's rare disease framework, the latest developments in the ongoing measles outbreak, and the growing use of peptide-based therapies. The interview ties together current public health concerns over measles with regulatory policy questions at the FDA and rising interest in peptides as a class of treatments.
- 6
US regulators have approved an artificial intelligence tool that analyses MRI scans to help estimate the risk of breast cancer returning in patients. The clearance means clinicians may soon use the software alongside standard imaging to guide follow-up care and treatment decisions. It adds to a growing list of AI-based medical devices authorised by the FDA for cancer care.
- 7Taylor Farms' Trump donation followed by FDA warning reversal●1. Taylor Farms gave $1 million to Trump's PAC. 2. Bruce Taylor met with Trump on 07/16. 3. The FDA reversed its warning
Critics are accusing produce giant Taylor Farms of buying favorable treatment after a $1 million donation to Donald Trump's PAC and a July 16 meeting between company head Bruce Taylor and Trump, days before the FDA reportedly reversed a food safety warning about the company on July 19. Opponents are calling for a boycott and questioning FDA independence.
- 8Disc Medicine's Bitopertin Hits Phase III Goals●Disc Medicine’s Bitopertin Nails Phase III Endpoints, Eyes FDA Resubmission
Disc Medicine announced that its drug bitopertin met its Phase III clinical trial endpoints, clearing the way for a planned resubmission to the US Food and Drug Administration. The results mark a key milestone for the biotech company, whose lead therapy is being developed for blood disorders, and set the stage for a potential regulatory decision in the United States.
- 9
The US Food and Drug Administration has approved a new medicine for weight loss, according to reports from international outlets including Polish Radio and Olhar Digital. Details about the drug's name, manufacturer and trial results were not specified in the available coverage. The decision adds to a fast-growing market of obesity treatments that has drawn global attention from patients, doctors and pharmaceutical companies.