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2,810 stories matching this filter · ← front page

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STAT1776Endpoints1386Fierce Biotech704BioSpace695BioPharma Dive524raps234onclive165fda recalls112
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  • Congress must restore independence of scientific advisory panels after controversial firings
    The authors note the recent dismissal of two vice chairs of the U.S. Preventive Services Task Force by HHS Secretary Robert F. Kennedy Jr., stressing the panel’s role in reviewing evidence to guide…
    STAT · 11d agoRegulatoryNegative↗ source
  • STAT reporters outline how upcoming midterms could reshape US vaccine, drug policy and the MAHA movement
    STAT's weekly video series STATus Report aired from Boston, the historic heart of American democracy, as the nation heads toward the midterm elections. The episode features reporters from the D.C.…
    STAT · 11d agoNeutral↗ source
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  • FDA and CMS work to prevent regulatory clash as states move to test clinical AI
    Officials at the FDA and CMS are working behind the scenes to avoid a regulatory clash as more states plan to test artificial intelligence tools that perform clinical tasks. The tension arises fro…
    STAT · 11d agoRegulatoryNeutral↗ source
  • Nova Biomedical issues safety instructions for StatStrip Glucose Hospital Meter Gen 2.0
    Nova Biomedical has sent a letter to customers using the StatStrip Glucose Hospital Meter System Gen 2.0, advising updated use instructions while a software fix is prepared. The FDA classified the…
    fda medwatch · 11d agoCRLNegative↗ source
  • FDA rolls out new inspection coordination plan, lifts estradiol patch warning and HHS permits compounding of six peptides
    FDA's drug center and inspections office have agreed on a new concept of operations (ConOps) to better coordinate inspections and compliance activities. A U.S. senator introduced draft legislation…
    raps · 11d agoRegulatoryNeutral↗ source
  • STAT+: Pharmalittle: We’re reading about AstraZeneca cost-cutting, Sun Pharma facility problems, and more
    AstraZeneca has launched a three-year cost-cutting program that aims to slice off $1.5 billion a year, with the savings reinvested in R&D.
    STAT · 11d agoRegulatoryNeutral↗ source
  • Patient billed $1,756 after routine urgent-care visit for UTI at Texas clinic
    A woman in Allen, Texas thought she was getting a standard urgent‑care treatment for a urinary tract infection. She provided a urine sample, received a diagnosis and a prescription, and paid a mode…
    STAT · 11d agoNegative↗ source
  • Election stress linked to higher risk of arrhythmias and heart attacks, study finds
    Elections can create heightened stress that may affect cardiovascular health, according to recent research. The study highlights a link between the emotional strain of voting periods and increased…
    STAT · 11d agoNegative↗ source
  • Lancet series highlights men’s health paradox and rising urgent-care costs
    The Lancet has launched a new series examining why men consistently experience poorer health outcomes than women despite advantages in certain areas. The series points to gaps in research, screeni…
    STAT · 11d agoNegative↗ source
  • Vir Biotechnology appoints David Liu as chief medical officer
    Vir Biotechnology announced the hiring of David Liu as its new chief medical officer. Liu joins the company after serving as chief medical officer at Nuvation Bio, where he held the same position.…
    STAT · 11d agoNeutral↗ source
  • 1834 measles letter highlights historic roots of today's anti-vaccine sentiment
    Jim Downs, a medical historian, examined a 1834 letter from Jane Butt in a London journal while at Yale's medical library, noting the date matches 192 years later. Butt described a measles outbrea…
    STAT · 11d agoNeutral↗ source
  • Genmab shares jump as petosemtamab plus Keytruda halves death risk in head-neck cancer trial
    Genmab reported that a late-stage study of its experimental antibody petosemtamab combined with Keytruda cut the risk of death by about 50 percent compared with Keytruda alone in patients with PD‑L…
    BioPharma Dive · 12d agoPositive readoutPositive↗ source
  • Labor Dept finalizes PBM disclosure rule to boost transparency for self-insured employers
    The U.S. Labor Department has finalized a rule that will require pharmacy benefit managers to disclose detailed fee and compensation information to self-insured employer clients, with the requireme…
    BioPharma Dive · 12d agoRegulatoryNeutral↗ source
  • Voters demand action on soaring health-care costs, boosting support for Medicare for All
    Recent polls show Americans increasingly worried about the rising cost of health care, with many saying it is their top financial concern. Voter anger is directed at politicians, who are seen as f…
    STAT · 12d agoNegative↗ source
  • Federal rule forces PBMs to disclose fees and rebates to employers
    The Trump administration finalized a regulation that will require pharmacy benefit managers (PBMs) to reveal the various fees and compensation they receive from drugmakers, consultants and other pa…
    STAT · 12d agoRegulatoryPositive↗ source
  • Vertex kidney disease drug faces infection risk scrutiny ahead of FDA decision
    Vertex's kidney disease therapy is expected to receive FDA approval, with the agency's decision scheduled for Nov 30. A previously undisclosed pause rule has drawn attention, raising concerns abou…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Flagship Pioneering merges three biotech startups to launch AI-driven drugmaker Etcelera
    Flagship Pioneering announced the creation of Etcelera Therapeutics by merging three of its portfolio companies - Etiome, Cellarity and Empress Therapeutics. The new venture will combine artificia…
    BioPharma Dive · 12d agoDealPositive↗ source
  • 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
  • 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
  • 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