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2,738 stories matching this filter · ← front page

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  • 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 · 14d agoApprovalPositive↗ source
  • 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 · 14d agoRegulatoryPositive↗ source
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  • 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 · 14d agoRegulatoryNeutral↗ 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 · 14d 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  • FDA issues revised draft guidance for drug-device combination product performance
    The U.S. Food and Drug Administration has released a revised draft guidance aimed at helping sponsors of drug-device combination products develop essential drug delivery device performance characte…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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d 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 · 14d ago↗ source
  • HHS to allow compounders to make 6 unapproved peptides
    RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the FDA in July.
    BioPharma Dive · 14d 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 · 15d agoPositive readoutPositive↗ 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 · 15d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance to streamline approval of personalized gene therapies
    The FDA announced a draft guidance aimed at expanding access to gene therapies that target different mutations within the same disease. The proposal outlines an "individualized feature space" that…
    BioPharma Dive · 15d agoRegulatoryPositive↗ source
  • Eli Lilly to merge U.S. and international units after exec retirement; Novartis records $1.9B impairment on failed Avidity drug
    Eli Lilly announced that its U.S. and international divisions will be combined into a single unit called "Lilly Global Markets" after the retirement of long‑time executive Patrik Jonsson at the end…
    BioPharma Dive · 15d agoNeutral↗ source
  • Epic's data‑blocking tactics curb health‑tech innovation, investigation finds
    A STAT investigation reveals that Epic Systems, the leading electronic health record vendor, is deliberately limiting access to patient data for competing software developers. This practice gives E…
    STAT · 15d agoNegative↗ source
  • HHS adopts temporary policy to let compounding pharmacies produce six unapproved peptides
    HHS announced a temporary policy that grants enforcement discretion to state-licensed compounding pharmacies, federal facilities, and licensed physicians who compound six specific peptide products…
    STAT · 15d agoRegulatoryNeutral↗ source
  • Lawmaker asks GAO to examine TrumpRx claims of $700 million drug savings
    Representative Frank Pallone, the ranking member of the House Energy and Commerce Committee, sent a letter to the Government Accountability Office asking it to assess whether the TrumpRx website ha…
    STAT · 15d agoRegulatoryNegative↗ source
  • Epic’s dominance forces health-care AI firms to adapt, new STAT+ analysis finds
    The latest STAT+ AI Prognosis newsletter examines how Epic’s entrenched position in electronic health-record systems is shaping the strategies of health-care artificial-intelligence companies. The…
    STAT · 15d agoNeutral↗ source