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  • New tumor atlas reveals why colorectal cancer is more aggressive in younger patients
    Researchers have created a new atlas that catalogs 189 colorectal tumor samples from patients aged in their 20s to 90s, aiming to clarify why cancers that arise early are harder to treat. The coll…
    STAT · 12d agoPositive↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 12d agoApprovalPositive↗ source
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  • EMA and African regulator issue joint guidance to accelerate Ebola vaccine trials
    The European Medicines Agency and its African counterpart have released a joint position paper aimed at facilitating Ebola vaccine research. The guidance is intended to help launch clinical trials…
    raps · 12d agoRegulatoryPositive↗ source
  • Eli Lilly leans on cash-pay model to grow obesity drug sales in US and overseas
    Eli Lilly has observed that patients in the United States are prepared to pay several hundred dollars each month for treatments targeting obesity. The company has focused on a cash-pay approach, s…
    Endpoints · 12d agoNeutral↗ source
  • Dren Bio secures $350 million to advance blood-cancer therapy toward 2027 launch
    Dren Bio, a California biotech firm, announced it has closed a financing round that raised $350 million. The funding will be directed toward developing its lead blood‑cancer drug, with the company…
    Endpoints · 12d agoDealPositive↗ source
  • Treasury's Proposed China Investment Rule Sparks Debate Over Licensing Exemptions
    The U.S. Treasury Department recently proposed a rule that would limit American investment in Chinese biotechnology companies, prompting immediate discussion among industry stakeholders. Commentat…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Medline orders removal of all brand beds and accessories over fire and asphyxiation hazards
    Medline has issued an urgent field safety notice indicating that all of its branded hospital beds and related components must be removed or corrected because of identified safety risks. The FDA’s…
    fda medwatch · 12d agoRegulatoryNegative↗ source
  • HHS issues interim policy allowing compounding of six unapproved peptides under set conditions
    HHS announced an interim policy that will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug su…
    raps · 12d agoRegulatoryNeutral↗ source
  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…
    raps · 12d agoRegulatoryNeutral↗ source
  • Michigan Senate candidate El-Sayed rebuts RFK Jr. and highlights FDA's new enforcement discretion on peptide drugs
    Abdul El-Sayed, the Democratic Senate hopeful in Michigan, pushed back against recent statements made by RFK Jr., defending his own health-care positions and emphasizing his background as an immigr…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Rising employer health premiums pressure workers as industry resists change
    Workers are currently choosing health plans for the upcoming year as average family premiums for employer coverage climb to $28,303 in 2026, a 28% increase over the past five years. Employers cont…
    STAT · 12d agoNegative↗ source
  • AI as partner, competitor or crutch? Biologists weigh benefits and risks
    In a recent STAT+ opinion, UC Davis cell biology professor Paul Knoepfler discusses how artificial intelligence is reshaping biomedical research. He acknowledges AI's ability to accelerate experim…
    STAT · 12d agoNeutral↗ source
  • Federal judge blocks narrow Medicaid frailty definition, expanding work-requirement exemptions
    Federal judge Richard D. Stearns in Massachusetts issued a permanent injunction against the new federal definition of “medical frailty” used to limit Medicaid work‑requirement exemptions. The judg…
    STAT · 12d agoRegulatoryNeutral↗ source
  • HHS permits compounding of six experimental peptides despite FDA scientists' safety concerns
    HHS issued a temporary policy that lets licensed pharmacies and physicians compound six experimental peptides without risk of federal enforcement. The list includes the injury-recovery duo BPC-157…
    STAT · 12d agoRegulatoryPositive↗ source
  • HHS issues temporary policy permitting compounding pharmacies to produce certain peptide drugs
    The U.S. Department of Health and Human Services announced a new policy that temporarily authorizes compounding pharmacies to manufacture specific peptide products that are not otherwise commercial…
    STAT · 12d agoRegulatoryNeutral↗ source
  • SLR Food Distribution recalls Wise Wife ground cinnamon over possible lead contamination
    SLR Food Distribution Inc., based in Hicksville, New York, announced a voluntary recall of its Wise Wife brand ground cinnamon. The recall was issued because the product may be contaminated with e…
    fda recalls · 12d agoRegulatoryNegative↗ source
  • STAT Health Tech newsletter previews EPIC probe, Teladoc surprise and AI payment challenges
    The latest STAT Health Tech newsletter, authored by correspondent Mario Aguilar, highlights several emerging topics in health technology. It flags an upcoming investigation into EPIC, the electroni…
    STAT · 12d agoNeutral↗ source
  • RFK Jr. Addresses Iowa Rally Calling for Covid Vaccine Removal and Highlighting MAHA Movement
    At a rally in Clive, Iowa, a group calling themselves Make America Healthy Again gathered with Republican candidates to criticize big agriculture and demand the removal of the Covid-19 vaccine from…
    STAT · 12d agoNeutral↗ source
  • Biostatistician Martin Kulldorff Criticizes NIH Gatekeepers Over Measles Claims
    Martin Kulldorff, a biostatistician known for his opposition to Covid lockdowns, delivered a lecture at the National Institutes of Health in which he challenged the role of scientific gatekeepers.…
    STAT · 12d agoNeutral↗ source
  • STAT+: Federal judge rejects new Medicaid ‘frailty’ definition for work requirements
    A judge ruled that federal regulators exceeded their authority in narrowing the exceptions to Medicaid work requirements for people with medical issues.
    STAT · 12d ago↗ source
  • Lilly's retatrutide outperforms Ozempic in weight loss and blood sugar reduction in head-to-head diabetes trial
    Eli Lilly reported that its experimental drug retatrutide showed greater efficacy than Novo Nordisk’s Ozempic in a large diabetes trial. After 80 weeks, participants receiving the highest dose of…
    STAT · 13d agoPositive readoutPositive↗ source
  • FDA outlines pathway for approval of personalized gene-editing therapies
    The U.S. Food and Drug Administration released a set of recommendations describing how developers can pursue regulatory approval for gene-editing treatments that are customized to a single patient’…
    Endpoints · 13d agoRegulatoryNeutral↗ source
  • AstraZeneca’s heart drug Wainua fails late-stage trial, raising 2027 outlook concerns
    AstraZeneca announced that its experimental heart disease therapy, Wainua, did not meet primary endpoints in a Phase III trial conducted in July. The failure is a setback for the company, whose pi…
    Endpoints · 13d agoNegative readoutNegative↗ source
  • Pfizer shuts India cancer drug plant for up to two years, worsening drug shortages
    Pfizer has temporarily closed a manufacturing site in India that produces several cancer medicines. The company says the facility will remain idle for as long as two years while it addresses the i…
    Endpoints · 13d agoRegulatoryNegative↗ source
  • FDA drafts guidance to speed approvals of individualized gene therapies, hailed as win for rare disease patients
    The U.S. Food and Drug Administration released draft guidance aimed at streamlining the approval process for certain individualized gene therapies. The proposal would allow sponsors to avoid filing…
    STAT · 13d agoRegulatoryNeutral↗ source