FDA Lists More Than 1,500 AI-Enabled Medical Devices as Oncology Applications Expand
oncodaily - The U.S. Food and Drug Administration (FDA) has listed more than 1,500 artificial intelligence-enabled medical devices authorized for marketing in the United States, reflecting the growing integration of AI across […]
AI Summary: The FDA catalogued more than 1,500 AI‑enabled medical devices, spurring criticism that most were cleared without direct evidence they improve patient outcomes. Regulators and clinicians face mounting calls for post‑market studies and transparency, balancing enthusiasm for AI innovation against the sober question: do these devices actually help patients?
Ultragenyx Gene Therapy Becomes First FDA-Approved Treatment for Ultra-Rare Disease
Frank Vinluan / medcitynews - Ultragenyx Pharmaceutical’s Genglycos received accelerated FDA approval for glycogen storage disease type Ia, an inherited enzyme deficiency. It’s also the first approved gene therapy for Ultragenyx, which specializes in rare disease treatments. The post …
AI Summary: Ultragenyx received FDA approval for a gene therapy, marking the first approved treatment for that particular ultra‑rare disorder. The decision provides a regulated therapeutic option for patients previously without approved care, highlighting the evolving regulatory willingness to greenlight transformative but small‑population medicines.
How Cyclospora Evaded the U.S. Food Safety System to Sicken Thousands
Christina Jewett and Julie Creswell / nytimes - The Trump administration delayed a rule last year that could have sped up the effort to pinpoint the source of the contamination. Critics charge that food safety oversight has eroded overall.
AI Summary: An extensive Cyclospora outbreak has sickened thousands, revealing how fecal contamination slipped into the food chain and into public health blind spots. Investigations point to the parasite’s movement through human waste and lapses in detection and prevention, prompting renewed scrutiny of inspection systems and calls for tighter controls to stop another avoidable wave.
FDA Grants Accelerated Approval to Bristol Myers Squibb’s Zenbexus Plus Daratumumab and Hyaluronidase-fihj and Dexamethasone for Multiple Myeloma
oncodaily - The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj and dexamethasone (ZDd) for adults with multiple myeloma who have […]
AI Summary: Bristol Myers Squibb secured FDA approval of a first‑in‑class protein‑degrader regimen for multiple myeloma, cleared as a combination with daratumumab, hyaluronidase and dexamethasone. The nod marks a notable shift toward targeted degrader strategies in hematologic oncology and gives clinicians another option for patients with advanced disease.
FDA advisers to weigh cancer blood test
Ella Jeffries / beckershospitalreview - The FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee will meet Sept. 23 to discuss and vote on Grail’s premarket approval application for its Galleri blood test, according to a notice published Aug. 10 in the Federal R…
AI Summary: FDA advisors are set to review a multi-cancer early-detection blood test, weighing evidence on accuracy, clinical utility, and how to handle follow-up diagnostics. Regulators must decide whether the test meets approval standards for broad screening, balancing potential earlier cancer detection against risks of false positives, overdiagnosis, and costly downstream workups.
FDA Approved Pluvicto Plus ARPI for PSMA-Positive mAPMN/S Prostate Cancer
oncodaily - On July 31, 2026, the US Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan, marketed as Pluvicto, in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults […]
AI Summary: The FDA has approved an expanded use for a lutetium‑177 radiopharmaceutical (Pluvicto), broadening access for PSMA‑positive metastatic prostate cancer patients and potentially speeding the adoption of targeted radionuclide therapy. Clinicians note the approval could shift treatment sequencing and patient pathways, with implementation details and eligibility criteria guiding real‑world impact.
- Access, dose optimization and real-world data for Lu-177 (4)
- FDA expands Pluvicto approval; industry reaction (3)
- PSMAddition trial: earlier Lu-177 delays metastatic progression (5)
Access, dose optimization and real-world data for Lu-177
FDA expands Pluvicto approval; industry reaction
PSMAddition trial: earlier Lu-177 delays metastatic progression
FDA approves first drug for full range of narcolepsy symptoms
medicalxpress - The U.S. Food and Drug Administration has approved Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults. Orzeyful marks the first medication approved for the full range of symptoms associated with narcolepsy type 1 and is the first approved…
AI Summary: The FDA has approved a medication that treats the full range of narcolepsy symptoms, including excessive daytime sleepiness and cataplexy, marking the first such comprehensive option for patients with narcolepsy type 1. Clinicians now have a single, regulated choice to address multiple debilitating symptoms rather than juggling piecemeal therapies.
Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA
Frank Vinluan / medcitynews - Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than four months. The FDA nod for Replimune’s oncolytic viral therapy, Tudriqev,…
AI Summary: After two previous turns in the penalty box, the FDA granted accelerated approval to Replimune’s oncolytic immunotherapy Tudriqev (RP1) in combination with nivolumab for advanced melanoma. The decision follows a favorable advisory committee outcome and positions a once-spurned viral-based therapy back into the clinic as a new option for patients with limited choices.
- Clinical community reaction and rollout: experts and training (4)
- Regulatory comeback: FDA approves Tudriqev after two rejections (4)
- Replimune announcements and company leadership reactions (3)
- All Other Stories
Clinical community reaction and rollout: experts and training
Regulatory comeback: FDA approves Tudriqev after two rejections
Replimune announcements and company leadership reactions
All Other Stories
FDA approves Moderna’s mRNA flu vaccine
Ella Jeffries / beckershospitalreview - The FDA has approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based influenza vaccine in the U.S., for the prevention of seasonal influenza in adults ages 50 and older. The decision follows a monthslong regulatory process that included the agency’s …
AI Summary: The FDA has approved Moderna's mRNA flu vaccine, giving the familiar seasonal bug a high-tech reboot. Regulators cleared Moderna’s mRNA formulation for public use, signaling a shift toward next-generation influenza vaccines; rollout details, target groups and supply plans will follow as public health authorities coordinate distribution for the coming flu season.
- FDA's reversal and approval of Moderna mRNA flu shot (3)
- Public health guidance and flu season preparedness (3)
- What mFLUSIVA approval means for policy, coverage and mRNA (3)
FDA's reversal and approval of Moderna mRNA flu shot
Public health guidance and flu season preparedness
What mFLUSIVA approval means for policy, coverage and mRNA
FDA approves Simtriyo for treating ADHD in children and adults
medicalxpress - The U.S. Food and Drug Administration has approved Simtriyo (centanafadine) for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults and children 6 years and older weighing ≥20 kg.
AI Summary: The FDA granted approval for Simtriyo to treat attention‑deficit/hyperactivity disorder in children and adults, adding a new prescription option to the ADHD toolkit. Regulators highlighted efficacy and safety data supporting the decision; clinicians and patients will now weigh the drug’s profile against existing therapies as rollout and coverage decisions play out.
As Cyclospora Cases Climb, FDA Official Says Food Supply Is Safe
Julie Creswell / nytimes - The acting deputy commissioner for food said the agency was taking action even though finding the root cause of the outbreaks is difficult.
AI Summary: Health authorities are tracking a rising number of cyclospora infections while stressing the overall safety of the food supply. Officials urged vigilance and proper food handling, noting some patients experience severe gastrointestinal illness. Public health experts warned that recurring outbreaks raise concerns about vulnerabilities in produce safety and monitoring systems.
- Iceberg lettuce link: multistate traceback and restaurant impacts (4)
- Public health strain: FDA reassures, experts warn, symptoms and travel (5)
- Scope and toll: exploding cases, hospitalizations and first U.S. deaths (6)
- All Other Stories
Iceberg lettuce link: multistate traceback and restaurant impacts
Public health strain: FDA reassures, experts warn, symptoms and travel
Scope and toll: exploding cases, hospitalizations and first U.S. deaths
All Other Stories
Prediction Market Betting on Drug Trials and Approvals Sparks Concern About Undermining Research
Rebecca Robbins / nytimes - Prediction markets on Kalshi and Polymarket now let people wager money on drug approvals. Kalshi also plans to allow bets on clinical trial results.
AI Summary: Betting platforms have started offering markets on clinical trial outcomes and FDA decisions, stirring alarms among regulators and researchers. Critics warn these markets could incentivize insider trading, leak-sensitive information, or distort trial conduct, prompting calls for oversight and clearer rules to protect scientific integrity and participant safety — because apparently Wall Street needed another hobby.
FDA Approves Belzutifan with Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma
esmo - Evidence for efficacy is based on the results from the LITESPARK-022 study
AI Summary: Regulators have cleared the combination of belzutifan and pembrolizumab as adjuvant therapy for renal cell carcinoma at high risk of recurrence after nephrectomy. Clinical data showed improved disease‑free survival versus control, offering a new post‑surgery option intended to delay recurrence in patients with residual recurrence risk.
US court rules abortion pill restrictions 'unlawful'
medicalxpress - A federal court in Virginia has ruled that restrictions imposed by the U.S. drug regulator on the abortion pill mifepristone are "unlawful" and ordered the Trump administration to reconsider them.
AI Summary: A U.S. court ruled recent restrictions on the abortion pill unlawful, reaffirming FDA regulatory standards and restoring broader access. Industry groups filed briefs backing FDA oversight, warning that legal uncertainty would harm patients and research. The ruling calms access for now while legal and policy debates continue.
$10B M&A Deal Pays Off With GSK’s First Lung Cancer Drug Approval
Frank Vinluan / medcitynews - GSK drug Jideytro received FDA approval for treating advanced cases of non-small cell lung cancer driven by ROS1 alterations. This molecule came from Nuvalent, which GSK recently acquired for $10.6 billion. The post $10B M&A Deal Pays Off With GSK’s First…
AI Summary: GSK has won FDA approval for its first lung cancer drug, a gene-targeting therapy that validates the company’s heavy investment and recent M&A strategy. The approval follows pivotal trial evidence of clinical benefit and positions GSK competitively in thoracic oncology, offering a new therapeutic choice for patients with the relevant molecular profile.
Children's cereals promise breakfast fun and nutrition, but are still high in sugar
medicalxpress - Many of us have grown up hearing the mantra that breakfast is the most important meal of the day, yet children's cereals fall short of that standard. That is the takeaway of new research analyzing child-targeted cereals in Canada.
AI Summary: Two investigative reports show major children's breakfast cereals remain high in added sugars despite branding that implies nutrition and fun. Public health advocates warn the products contribute to unhealthy diets in kids and call for clearer labeling and stricter marketing standards to parents and regulators.
A Peptide Showdown: F.D.A. Scientists May Clash With R.F.K.’s Agenda
Christina Jewett and Dana G. Smith / nytimes - Agency scientists are advising against allowing widespread use of several peptide injections. Robert F. Kennedy Jr., the health secretary, has said people should be free to experiment.
AI Summary: Federal regulators have zeroed in on a set of peptide injections gaining traction among wellness influencers and endorsed by RFK Jr., prompting internal debates about safety, evidence and regulation. FDA scientists are reviewing the products' claims and potential risks, setting up a clash between celebrity-driven demand and the agency’s evidence-based caution.
- Advisory panel votes to expand compounding despite safety warnings (4)
- FDA review and RFK Jr. clash over influencer‑favored peptides (4)
- Market hype and regulation: guidances, reporting and uncertainty (5)
Advisory panel votes to expand compounding despite safety warnings
FDA review and RFK Jr. clash over influencer‑favored peptides
Market hype and regulation: guidances, reporting and uncertainty
Taylor Farms Expands Iceberg Lettuce Recall to 27 States Amid Cyclospora Outbreak
Christina Jewett and Julie Creswell / nytimes - The implicated products were marketed under several brands, and had been shipped as recently as Thursday.
AI Summary: Taylor Farms has widened an iceberg-lettuce recall to 27 states after a Cyclospora outbreak sickened consumers. Health officials are urging anyone who purchased affected product to discard it and seek medical care if symptoms appear, while investigators trace distribution channels to pinpoint the contamination source. Yes, the lettuce did more than just wilt.
- FDA retraction and ongoing source investigations (3)
- Outbreak scale and clinical testing surge (3)
- Taylor Farms recall, company fallout and political scrutiny (3)
FDA retraction and ongoing source investigations
Outbreak scale and clinical testing surge
Taylor Farms recall, company fallout and political scrutiny
FDA approves a first-of-its-kind pill to cut cholesterol in high-risk patients
abcnews - The Food and Drug Administration has approved a first-of-its-kind pill that can drastically reduce cholesterol
AI Summary: The FDA approved a first‑of‑its‑kind oral cholesterol medication intended to lower LDL in high‑risk patients, offering a cheaper, pill‑based alternative to costly PCSK9 injections. Regulators cleared the treatment after reviewing trial data showing substantial LDL reductions, positioning it as a potentially more accessible option for long‑term cardiovascular risk management.
The US is hooked on unregulated peptides. But are they effective, or even safe?
livescience - The world of peptides has exploded in wellness circles, but the benefits of injecting these gray-market molecules rest on little clinical evidence.
AI Summary: Unregulated peptide products have proliferated in the US, raising safety and efficacy concerns as federal regulators convene a contentious panel that includes proponents of these off‑label compounds. The debate highlights a market gap where hype often outpaces evidence — and where regulators must decide whether to tidy up the wild west or watch it fester.
- FDA advisory showdown: whether to rein in wellness peptides (4)
- Gray-market surge: safety, evidence gaps and booming trade (4)