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1,295 stories matching this filter · ← front page

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  • DSV A/S reports manager share transactions in latest company announcement
    DSV A/S issued Company Announcement No. 1171, informing the market of recent share transactions carried out by a company manager. The disclosure is made under Article 19 of EU Regulation 596/2014,…
    globenewswire health · 21d agoRegulatoryNeutral↗ source
  • Lilly's obesity drug shows strong weight loss but fails to demonstrate cardiovascular benefit in heart disease trial
    Eli Lilly released Phase 3 results for its next‑generation obesity therapy retatrutide, showing it produces substantial weight loss in a trial of nearly 2,000 participants with severe obesity and e…
    STAT · 22d agoNegative readoutNeutral↗ source
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  • Eli Lilly's retatrutide shows strong weight loss but no clear heart risk reduction in Phase 3 trial
    Eli Lilly released new data from a Phase 3 trial of retatrutide, its next‑generation obesity drug. The study enrolled nearly 2,000 participants with severe obesity and existing heart disease, some…
    STAT · 22d agoNegative readoutNegative↗ source
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 22d agoRegulatoryNeutral↗ source
  • EMA moves quickly to enforce clinical trial result reporting across Europe
    The European Medicines Agency announced new measures aimed at ensuring that results of clinical trials are posted publicly in line with legal obligations. The steps follow an analysis that found f…
    STAT · 22d agoRegulatoryPositive↗ source
  • Sanofi's Lantus Solostar insulin pen faces supply challenges, patients struggle to find product
    Sanofi's Lantus Solostar pen, a long-acting insulin glargine product, has become hard to locate in pharmacies. The company says demand has risen due to broader market dynamics, and while the FDA h…
    STAT · 22d agoNegative↗ source
  • Congress rushes health-care bills on price transparency and prior authorization before August recess
    Congress is trying to pass a bundle of health-care legislation in the final week before the House and Senate adjourn for the August recess. Lawmakers are focusing on measures that would increase p…
    STAT · 22d agoRegulatoryNeutral↗ source
  • FDA advisory panel to decide on compounding of synthetic peptides amid safety concerns
    The FDA advisory committee is meeting to consider whether compounding pharmacies should be allowed to manufacture seven specific synthetic peptides. Use of these peptides has grown in the United St…
    STAT · 22d agoRegulatoryNeutral↗ source
  • Senate health committee delays vote on Trump nominee for ASPR amid anti-vaccine controversy
    The Senate health committee postponed its vote on Sean Kaufman, the Trump administration’s pick to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). The delay came ju…
    STAT · 22d agoRegulatoryNegative↗ source
  • HHS, FDA and partners to convene experts on clinical AI standards
    The White House, the Department of Health and Human Services, the FDA and the Office of the National Coordinator for Health Information Technology are bringing together experts to discuss how clini…
    STAT · 22d agoRegulatoryNeutral↗ source
  • FDA peptide panel faces clash as Ebola outbreak kills over 1,000 and vaccine options remain limited
    The FDA is holding a two‑day panel on peptide therapeutics, and observers anticipate heated debate among regulators and industry. The African CDC reports the fastest‑growing Ebola outbreak, with m…
    STAT · 22d agoRegulatoryNeutral↗ source
  • Advocacy group Public Citizen petitions FDA to ban direct-to-consumer prescription drug ads
    Public Citizen has filed a petition with the U.S. Food and Drug Administration calling for a ban on direct-to-consumer advertising of prescription medicines. The group argues that such ads are des…
    STAT · 22d agoRegulatoryNegative↗ source
  • FDA advisory panel to debate allowing compounding pharmacies to produce unapproved peptides
    FDA advisers will convene on Thursday and Friday to discuss a proposal that would let compounding pharmacies manufacture seven synthetic peptides that are currently classified as unsafe for compoun…
    STAT · 22d agoRegulatoryNegative↗ source
  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 22d agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 22d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 22d agoRegulatoryNeutral↗ source
  • Podcast explores father's quest for ultra‑rare disease therapy, telehealth GLP‑1 prescribing probe and fugitive posing as biotech exec
    The latest episode of STAT’s "The Readout Loud" podcast examines three distinct stories that intersect with the biotech world. Hosts Allison DeAngelis and Elaine Chen sit down with colleagues Jason…
    STAT · 22d agoNeutral↗ source
  • New AMA billing codes set to increase maternity care costs
    The American Medical Association, acting on a recommendation from the American College of Obstetrics and Gynecology, will end the use of global payment codes for deliveries at the end of this year.…
    STAT · 22d agoRegulatoryNegative↗ source
  • Trump administration nominates Wisconsin emergency physician Timothy Westlake to lead SAMHSA
    President Trump nominated Timothy Westlake, an emergency physician from Wisconsin, to serve as assistant secretary of mental health and substance use and head of SAMHSA. Westlake brings decades of…
    STAT · 22d agoRegulatoryNeutral↗ source
  • New fee-for-service maternity billing to replace bundled global payment in 2027
    The American College of Obstetricians & Gynecologists (ACOG) announced that starting Jan. 1, 2027 the CPT codes used for maternity care will shift from a bundled "global obstetric payment" to a fee…
    STAT · 22d agoRegulatoryPositive↗ source
  • FDA advisory panel backs compounding of unapproved peptides BPC-157 and KPV
    An FDA advisory panel voted narrowly to recommend that compounding pharmacies be permitted to produce the unapproved peptides BPC-157 and KPV. The recommendation is seen as a victory for supporter…
    STAT · 21d agoRegulatoryPositive↗ source
  • U.S. health officials probe new cyclospora outbreak affecting 72 people
    Federal health agencies are looking into a recent cluster of illnesses caused by the parasite cyclospora, which leads to diarrhea. As of the latest report, 72 individuals have been identified with…
    STAT · 22d agoRegulatoryNeutral↗ source
  • Bipartisan Senate Bill Aims to Create Office of Men’s Health
    The U.S. Senate will introduce the Men’s Health Act on Thursday, led by Rep. Ruben Gallego (D‑Ariz.) with Rep. Roger Marshall (R‑Kan.) as a co‑sponsor. The legislation mirrors a similar bipartisan…
    STAT · 22d agoRegulatoryPositive↗ source
  • Senate health panel pushes CDC nominee vote to next week
    The Senate health committee announced that the vote on Erica Schwartz's nomination to lead the Centers for Disease Control and Prevention has been delayed until next week because too few senators w…
    STAT · 22d agoRegulatoryNeutral↗ source
  • Chairman of Urbo Bank purchases €25,000 of bank's subordinated bonds
    Urbo bankas UAB disclosed that its Chairman of the Board, Marius Arlauskas, acquired the bank's subordinated bonds. The acquisition covered 25 bonds with a total consideration of EUR 25,000 and wa…
    globenewswire health · 22d agoRegulatoryNeutral↗ source