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1,468 stories matching this filter · ← front page

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  • 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 · 20d 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 · 21d agoRegulatoryNegative↗ source
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  • 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 · 21d 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 · 21d 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 · 21d 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 · 21d agoRegulatoryNegative↗ 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 · 20d 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 · 21d 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 · 21d 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 · 21d 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 · 20d 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 · 20d 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 · 21d 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 · 20d 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 · 21d 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 · 21d 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 · 21d 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 · 21d agoDealNeutral↗ source
  • GSK secures FDA approval for lung-cancer drug Jideytro after $10.6 billion Nuvalent acquisition
    GSK received FDA clearance for Jideytro, a therapy for patients with metastatic non‑small cell lung cancer that have ROS1 gene alterations and have already been treated with another targeted drug.…
    BioPharma Dive · 21d agoApprovalPositive↗ source
  • Arrowhead’s plozasiran cuts triglycerides up to 81% in late-stage trials, shows promise for severe hypertriglyceridemia
    Arrowhead Pharmaceuticals reported positive data from two late-stage studies of its RNA-based drug plozasiran in adults with severe hypertriglyceridemia. The trials used a subcutaneous injection e…
    BioPharma Dive · 21d agoPositive readoutPositive↗ 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 · 21d agoNegative↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 22d agoDealPositive↗ 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 · 22d agoApprovalNeutral↗ source
  • Vertex's $10 billion Crinetics buyout draws investor doubts over premium price
    Vertex was the lone bidder in a planned $10 billion acquisition of Crinetics Pharmaceuticals, a California company that focuses on endocrine medicines. Crinetics currently markets a therapy for a…
    BioPharma Dive · 21d agoDealNegative↗ source
  • Trump threatens 200% tariffs on imported generic drugs to force U.S. production
    President Trump announced on Truth Social that generic drugs imported into the United States could face a 100% tariff starting Aug. 1, 2028, rising to 200% three years later. He framed the measure…
    BioPharma Dive · 21d agoRegulatoryNegative↗ source