New FDA-Approved Device Uses Electric Fields to Treat Pancreatic Cancer
discovermagazine - Learn more about the newly approved wearable treatment that disrupts pancreatic cancer tumor growth while letting patients continue daily life at home.
AI Summary: The FDA approved a wearable device that delivers alternating electric fields to disrupt pancreatic tumor growth, letting patients remain ambulatory while receiving treatment. Clinicians hail the noninvasive approach as a new adjunct to standard care, aiming to slow progression in a cancer that’s notoriously hard to treat — and yes, it literally plugs into hope.
FDA clears 1st blood test for Alzheimer’s in primary care
Ella Jeffries / beckershospitalreview - The first FDA-cleared blood test to assess Alzheimer’s disease in primary care is now available for patients age 55 and older with symptoms of cognitive decline. The test aims to help clinicians rule out Alzheimer’s by identifying individuals unlikely to …
AI Summary: Regulators cleared the first blood test for Alzheimer’s for primary‑care use while researchers published capillary sampling methods and analyses showing blood biomarkers’ promise for dementia diagnosis. Together these developments push biomarker testing out of specialty clinics and toward routine care — promising earlier detection, though concerns about population diversity, accuracy thresholds and rollout logistics remain.
FDA to reassess the safety of BHA, a preservative used in popular snack foods
go - Federal health officials will reassess the safety of a chemical called BHA used in foods including potato chips, cereals, frozen meals and meat products
AI Summary: U.S. regulators have moved to reevaluate butylated hydroxyanisole (BHA), a common food preservative, ordering a fresh safety review after mounting evidence and public concern. The reassessment could lead to updated guidance or restrictions — which will delight activists and mildly inconvenience snack manufacturers.
BridgeBio Stands Tall as Phase 3 Data Put Dwarfism Drug on Track for FDA Filing
Frank Vinluan / medcitynews - Infigratinib achieved statistically significant improvement in growth rate and body composition in a Phase 3 clinical trial that tested the BridgeBio Pharma drug in achondroplasia, the most common form of dwarfism. Regulatory submissions are planned for l…
AI Summary: BridgeBio reported statistically significant Phase 3 results for infigratinib in achondroplasia, showing improved growth rates and body composition, moving the program toward an FDA filing. The readout strengthens BridgeBio’s rare-disease momentum and sets the stage for regulatory discussions and potential market entry.
FDA refuses to review Moderna flu vaccine
Ella Jeffries / beckershospitalreview - Moderna has received a refusal-to-file letter from the FDA’s Center for Biologics Evaluation and Research for its biologics license application for mRNA-1010, its investigational seasonal influenza vaccine. The letter, signed by Vinayak Prasad, MD, chief …
AI Summary: Moderna’s mRNA flu vaccine application has been rejected by the FDA—Moderna received a refusal‐to‐file letter while accusing the agency of shifting its review standards. Multiple reports echo this regulatory setback, fueling industry concerns over consistent, transparent decision‐making.
AstraZeneca gets CRL for prefilled pen version of lupus drug Saphnelo
Anna Brown / endpoints - The FDA has handed AstraZeneca a complete response letter for the subcutaneous prefilled, self-injectable pen of Saphnelo for systemic lupus erythematosus (SLE), a month after the asset gained approval in Europe ...
AI Summary: AstraZeneca’s application to market its subcutaneous prefilled pen formulation of Saphnelo for treating lupus has hit a roadblock after the FDA issued a complete response letter. The decision delays the drug’s approval and raises questions about its future in the competitive immunotherapy market.
Letters, Jan. 27, 2026: ‘A Team Canada must be assembled’ to help diversify trade
Jeffrey Morgan / calgarysun - Need to diversify I just watched a video detailing the prior commercial trading practices between Canada and the U.S. It makes me realize there is nothing more important than Canada diversifying its trade with other countries. By ‘nothing,’ I mean all pro…
AI Summary: Summit Therapeutics announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for Ivonescimab—intended for patients with EGFR‑mutated non‑small cell lung cancer who have progressed after TKI therapy. The regulatory nod signals a promising step forward in targeted lung cancer treatment.
FDA lifts hold on one of two Phase 3 gene editing studies by Intellia
Lei Lei Wu / endpoints - The FDA has allowed Intellia Therapeutics to resume one of its two pivotal trials of a gene editing therapy for transthyretin amyloidosis, which is a disease caused by misfolded proteins. Intellia
AI Summary: U.S. regulators have just cleared Intellia Therapeutics’ Phase 3 study of a gene‐editing therapy intended to treat a genetic nerve disorder, effectively rescinding a clinical hold. This development opens the door to renewed patient enrolment and further evaluation of the treatment’s safety and effectiveness.
Oregon baby is still battling infant botulism after ByHeart formula exposure
go - A Portland, Oregon, baby got sick with infant botulism after drinking contaminated ByHeart formula donated through a program that helps poor and homeless families
AI Summary: Two reports describe how a Portland baby continues to struggle with severe infant botulism after ingesting contaminated ByHeart formula distributed via a charity, raising concerns about quality control and the safety of aid programs.
F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds
Pam Belluck / nytimes - A study of more than 5,000 pages of agency documents on mifepristone over 12 years found that agency leaders almost always followed the evidence-based recommendations of scientists.
AI Summary: New in‑depth analyses of internal FDA documents reveal that regulatory decisions on the abortion pill mifepristone were firmly based on thorough evidence rather than political pressure, dispelling common misconceptions about politicized review processes.
FDA rejects cancer therapy for rare post-transplant disease
Ella Jeffries / beckershospitalreview - Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel). The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support …
AI Summary: The FDA has again rejected Atara’s cell therapy aimed at treating rare post‐transplant complications linked to Epstein–Barr virus. Despite high hopes for this innovative approach, regulatory concerns remain over its safety and efficacy—clearly a “repeat performance” in the world of breakthrough therapies.
FDA moves to remove suicide warnings from GLP-1 weight loss drugs
medicalxpress - Federal health regulators say popular weight loss drugs like Wegovy and Zepbound do not increase the risk of suicidal thoughts, and they have asked drugmakers to remove those warnings from medication labels.
AI Summary: In a surprising twist, the FDA has decided that the long‐rumored risk of suicidal ideation on popular GLP‑1 weight‐loss drugs may have been overblown. Regulators have now asked drugmakers – including Lilly and Novo Nordisk – to scrub these warnings from product labels, a move that is sure to spark both relief and raised eyebrows among critics.
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.