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1,295 stories matching this filter · ← front page

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  • 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
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  • Roche Diagnostics sales rise only 3% in H1 2026 as China pricing reforms weigh
    Roche Diagnostics reported sales of 6.73 billion Swiss francs for the first half of 2026, a 3% increase at constant exchange rates but a 3% decline in reported franc terms. Growth was limited by p…
    Fierce Biotech · 22d agoEarningsNegative↗ source
  • Clinuvel to relocate HQ to US and cut up to 20% of staff
    Clinuvel Pharmaceuticals, an Australian biotech, announced it will move its corporate headquarters to the United States starting Jan 1, 2027. The company said the shift is aimed at attracting U.S.…
    Fierce Biotech · 22d agoLayoffsNegative↗ 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
  • Formation Bio appoints veteran biotech leader Michael Ehlers as chief scientific officer
    Formation Bio, an AI-focused biotech, announced the hiring of Michael Ehlers, M.D., Ph.D., as its chief scientific officer and head of research and development. Ehlers brings a blend of academic a…
    Fierce Biotech · 21d agoPositive↗ 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 · 21d 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
  • Alm. Brand A/S discloses executive share transactions per EU regulation
    Alm. Brand A/S has issued a regulatory filing that details recent trading activity in its own shares by company executives and their related parties. The disclosure is made under Article 19 of EU…
    globenewswire health · 22d agoRegulatoryNeutral↗ source
  • Veterans Still Await Reinstatement After Trump's Promise to Restore Service for Covid Vaccine Refusers
    When the COVID-19 vaccine became available in 2020, President Trump said he would offer a path to redemption for service members who declined the shots. A year later, four veterans who sought rein…
    STAT · 22d agoNegative↗ source
  • Urbo Bank discloses board chair’s purchase of 25 subordinated bonds for €25,000
    Urbo Bank announced that its board chairman and administration head, Marius Arlauskas, bought 25 units of the bank’s subordinated bonds (ISIN LT0000135659). The purchase, amounting to €25,000, was…
    globenewswire health · 22d agoDealNeutral↗ source
  • Congo Ebola outbreak kills 999, fastest recorded spread with no approved vaccine
    Official data from Congo’s Ministry of Health shows that 2,473 Ebola cases have been recorded and 999 deaths have occurred, with 737 patients still in isolation. The outbreak, declared on May 15,…
    STAT · 23d agoNegative↗ source
  • FDA approves Merck’s oral PCSK9 inhibitor Lipfendra, but cardiologists question its immediate impact
    The FDA has granted approval to enlicitide, marketed by Merck as Lipfendra, marking the first oral PCSK9 inhibitor for lowering blood cholesterol. The drug arrives as new clinical guidelines encou…
    STAT · 23d agoApprovalNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 22d agoRegulatoryPositive↗ source
  • NIH joins Trump’s $5B AI Genesis Mission to boost biomedical research
    The U.S. Department of Health and Human Services announced that the National Institutes of Health will take part in the President’s Genesis Mission, a $5 billion AI-driven effort. The initiative a…
    Fierce Biotech · 23d agoRegulatoryPositive↗ source
  • Trump announces steep tariffs on imported generic drugs, starting 100% in 2028 and rising to 200% in 2029
    President Donald Trump disclosed a plan to levy heavy tariffs on generic medicines that are imported into the United States. The tariff would be set at 100 percent beginning in August 2028 and woul…
    STAT · 23d agoRegulatoryNegative↗ source