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1,770 stories matching this filter · ← front page

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  • FDA says it has not paused CRL releases amid transparency push
    An unnamed pharmaceutical company filed a citizen petition in April asking the FDA to change how it publicly releases Complete Response Letters, arguing the new policy conflicts with long‑standing…
    BioSpace · 28d 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 · 28d agoPositive↗ source
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  • 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 · 28d 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 · 29d 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 · 29d agoRegulatoryNeutral↗ source
  • Nordic biotech must unite to become a global force, say venture investors
    The latest episode of BioSpace's podcast Denatured features Ester Sklarsky of Sound Bioventures and João Ribas of Novo Holdings Seed Investments discussing the future of Nordic biotech. The guests…
    BioSpace · 29d agoNeutral↗ 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 · 29d 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 · 28d 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 · 28d 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 · 29d 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 · 28d 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 · 29d 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 · 29d 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 · 29d 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 · 29d 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 · 29d agoNegative↗ source
  • AstraZeneca’s rare disease drug Wainua fails Phase 3, narrowing path to $80 billion sales goal
    AstraZeneca announced that its rare disease therapy Wainua did not meet its primary endpoints in a Phase 3 trial, ending plans to broaden the drug’s label for transthyretin amyloidosis cardiomyopat…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion, boosting its role in cell therapy preservation
    Repligen announced a $1.5 billion acquisition of BioLife Solutions, a company whose CryoStor media is used to preserve cell therapies during storage and transport. BioLife’s products are employed…
    BioSpace · 1mo agoDealPositive↗ source
  • Eli Lilly’s $3.8 billion acquisition of AtaiBeckley signals strong backing for psychedelic therapeutics
    Novartis and Roche kicked off the second‑quarter earnings season, with other majors such as AstraZeneca, GSK and Biogen slated to follow. The earnings wave highlights continued revenue growth acros…
    BioSpace · 1mo 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 · 1mo agoApprovalNeutral↗ 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 · 29d agoRegulatoryPositive↗ source
  • Arrowhead reports Phase 3 data showing potentially best-in-class triglyceride reduction, eyes FDA filing
    Arrowhead Pharmaceuticals announced topline results from two late-stage Phase 3 trials (SHASTA-3 and SHASTA-4) of its siRNA drug plozasiran in patients with severe hypertriglyceridemia (sHTG). Th…
    BioSpace · 1mo agoPositive readoutPositive↗ 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 · 1mo agoRegulatoryNegative↗ source
  • Congressional panel warns US rare-disease lead is eroding and calls for supportive policies
    A Congressional advisory panel has urged the U.S. government to adopt policies that would help rare disease drug development, including a finalized FDA platform designation and the use of novel tri…
    BioSpace · 1mo agoNegative↗ source
  • House passes FDA Modernization Act 3.0 to push update of animal testing regulations
    The U.S. House approved the FDA Modernization Act 3.0, a bill aimed at modernizing preclinical testing rules. The legislation requires the FDA to revise regulations that still reference animal tes…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source