Nestlé recalls baby formula over toxin risk
medicalxpress - Nestlé has announced a global recall of some baby formula products, saying they may contain a toxin that can cause food poisoning in infants.
AI Summary: Nestlé has initiated a global recall of certain baby formula products after detecting potential toxin contamination that may cause food poisoning in infants. Affected lots are being removed from retail shelves while regulators and the company work to confirm the contamination’s extent and ensure consumer safety.
OpenAI Launches ChatGPT Health: 5 Things to Know
Katie Adams / medcitynews - OpenAI announced a new dedicated platform for health conversations. The company said the new offering is not intended for medical diagnosis or treatment — but rather to provide support for personal health navigation.The post OpenAI Launches ChatGPT Health…
AI Summary: OpenAI has rolled out ChatGPT Health, a dedicated platform enabling health‐focused conversations by integrating data from health apps and medical records. Although not intended for diagnosis, the move sparks wry remarks as the tech giant ventures boldly into sensitive, regulated health terrain.
FDA rejects Corcept’s cortisol-targeting drug for Cushing’s syndrome
Ayisha Sharma / endpoints - Corcept Therapeutics failed to secure US approval for its drug candidate as a hormonal disorder treatment. The FDA rejected Corcept’s selective cortisol modulator relacorilant for Cushing’s syndrome, according to a company
AI Summary: Corcept Therapeutics has hit a regulatory roadblock as the FDA rejected its cortisol‐targeting relacorilant, intended for hormonal disorders. The decision forces the company to reassess its strategy, highlighting the challenges inherent in advancing novel hormonal therapies amid strict regulatory scrutiny.
Foods with healthy-sounding buzzwords could be hiding added sugar in plain sight
medicalxpress - Many consumers feel pride in avoiding the glazed pastries in the supermarket and instead opting for "all natural" granola that comes packed with extra protein. Same goes for low-fat yogurts "made with real fruit," "organic" plant-based milks and bottled "…
AI Summary: Investigative posts reveal that foods flaunting “all‐natural” or “healthy” buzzwords can secretly pack in a surprising amount of added sugars, leaving consumers to wonder if their guilt‐free choices are anything but sweet. A reminder that not every label is as wholesome as it sounds.
Novo Nordisk’s Wegovy Pill Becomes First FDA-Approved Oral GLP-1 Drug for Weight Loss
Frank Vinluan / medcitynews - Beyond weight reduction and long-term maintenance of weight loss, the FDA decision for oral Wegovy covers use of the once-daily pill for reducing the risk of major cardiovascular events. Novo Nordisk expects the Wegovy tablet will launch in early January.…
AI Summary: The FDA has given its nod to Novo Nordisk’s oral GLP‑1 receptor agonist for chronic weight management – a historic first for an anti‑obesity pill. The approval offers patients a non‑injectable alternative, potentially transforming obesity care in a market hungry for innovation.
FDA Approved Rucaparib for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
oncodaily - On December 17, 2025, the FDA issued a regular approval for rucaparib (Rubraca®), marking the formal conversion of its earlier accelerated authorization into full approval for BRCA-mutated metastatic castration-resistant prostate […]
AI Summary: The FDA has granted full approval to rucaparib (Rubraca®) for treating adults with BRCA‐mutated metastatic castration‐resistant prostate cancer, converting its prior accelerated approval into standard approval. This landmark decision offers a new treatment option for patients with this genetic profile.
FDA Removes Key Limitation on the Use of Real-World Evidence in Regulatory Reviews
oncodaily - On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a significant update to its regulatory approach regarding the use of real-world evidence (RWE) in drug and medical […]
AI Summary: The FDA has dramatically loosened its long‐standing limitations on the use of real‐world evidence in regulatory reviews, signaling an era where big data may facilitate quicker approvals for innovative drugs. Officials are also urging early-phase trials reform to better capture real‐world outcomes.
FDA approves 1st gene therapy for Wiskott-Aldrich syndrome
Ella Jeffries / beckershospitalreview - The FDA has approved Waskyra (etuvetidigene autotemcel), the first gene therapy for Wiskott-Aldrich syndrome, a rare and life-threatening immune disorder. Waskyra is indicated for pediatric patients 6 months and older, as well as adults with Wiskott-Aldri…
AI Summary: In a landmark decision, the FDA approved Waskyra – the first gene therapy for Wiskott‐Aldrich syndrome – offering new hope for patients with this rare and life‐threatening immune disorder. The agency’s flexible approach in handling rare disease treatments marks a turning point in precision medicine.
A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes
fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.
AI Summary: A dozen former FDA commissioners have fiercely criticized the proposed overhaul of U.S. vaccine regulations spearheaded by FDA official Vinay Prasad, warning it could undermine decades‐old safety standards and erode public trust in immunization.
FDA approves all ages gene therapy for spinal condition
Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …
AI Summary: The FDA has given the green light to Novartis’ gene replacement therapy Itvisma for the treatment of spinal muscular atrophy, a development that extends its use to patients of all ages. The approval, which responds to long‐standing concerns over safety and patient eligibility, marks a significant milestone in SMA care.
Novo submits high-dose Wegovy for FDA approval using voucher
Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...
AI Summary: Novo Nordisk has formally submitted its application to the FDA to approve a higher-dose formulation of its flagship obesity drug, Wegovy. Leveraging a recently secured priority voucher, the filing is set to potentially expand treatment options for weight management as the review process begins.
FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
oncodaily - What Does FDA Approval Mean? The U.S. Food and Drug Administration (FDA) evaluates new cancer therapies to determine whether they are safe and effective for clinical use. Approval is based […]
AI Summary: The U.S. Food and Drug Administration has approved a combination of pembrolizumab (Keytruda) and enfortumab vedotin (Padcev) for patients with muscle‐invasive bladder cancer who cannot tolerate cisplatin. Both agents—which have individually transformed treatment paradigms—are now linked in a perioperative setting that could alter outcomes for this aggressive cancer.
FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation
esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study
AI Summary: The FDA has granted full approval for ziftomenib—a novel agent aimed at treating relapsed or refractory acute myeloid leukemia, especially in patients with NPM1 mutations. Backed by the KO‐MEN‐001 trial data, this decision marks a significant step forward for a patient group in dire need of new therapeutic options.
F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause
Roni Caryn Rabin / nytimes - The benefits of hormone replacement have been underappreciated, Dr. Marty Makary, the agency’s commissioner, said on Monday. Critics described evidence for the change as insufficient.
AI Summary: In a bold policy pivot, the FDA will lift long‑standing black box warnings on hormone treatments for menopause. The decision – made without an official advisory committee’s input – updates labeling to better reflect current risk–benefit assessments, leaving critics to wonder if caution has finally given way to progress.
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths
go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year
AI Summary: The FDA has revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy, adding a boxed safety warning and stricter usage conditions following reports of two patient deaths. The update reflects mounting safety concerns that have prompted closer regulatory oversight.
Infant Formula Recall Expands as Botulism Outbreak Grows
Rylee Kirk / nytimes - Federal health officials said caregivers should stop using all ByHeart powdered formula products after 15 infants in 12 states were hospitalized.
AI Summary: ByHeart, a maker of organic baby formula, has expanded its nationwide recall after several infants were hospitalized with botulism symptoms. Federal health officials are urging caregivers to stop using all ByHeart powdered formula as investigations into the contamination continue.
Richard Pazdur Appointed Director of the FDA’s Drug Center: A New Chapter for Cancer Regulation
oncodaily - Dr. Richard Pazdur, one of the most influential figures in oncology drug regulation, has been appointed Director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and […]
AI Summary: The FDA has ushered in a new era in oncology drug oversight by appointing Dr. Richard Pazdur as the director of its Drug Center. The move comes amid agency challenges and staff cuts, promising stabilizing leadership at one of its most influential divisions.