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  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 11d agoRegulatoryNeutral↗ source
  • Juul receives FDA clearance for new e-cigarette with optional age-verification feature
    Juul Labs announced that the U.S. Food and Drug Administration has granted the company permission to market an updated version of its flagship vaping device. The new model, called Juul2, includes…
    STAT · 10d agoRegulatoryNeutral↗ source
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Infectious Disease444
  • FDA approves Roivant's new dermatomyositis therapy
    The FDA has granted approval to a therapy developed by Roivant for the treatment of dermatomyositis, a rare autoimmune condition that causes muscle inflammation and skin rash. The decision adds a…
    STAT · 11d agoApprovalPositive↗ source
  • Former CDC leaders resign, warn of lingering political interference and call for stronger public health safeguards
    Three former CDC officials-Debra Houry, Daniel Jernigan, and Demetre Daskalakis-announced they resigned from the agency last year. Their careers included senior roles in disease control, emerging i…
    STAT · 11d agoRegulatoryNegative↗ source
  • Daiichi Sankyo to restructure its commercial organization, appointing Ken Keller as chief commercialization officer
    Daiichi Sankyo announced plans to overhaul its commercial operations, with a split of its commercialization activities slated for April 1, 2027. The company has appointed veteran executive Ken Kel…
    Endpoints · 11d agoNeutral↗ source
  • Federal autism advisory panel reaffirms discredited theories amid vaccine controversy
    At a recent meeting of the federal autism advisory committee, members again promoted theories linking vaccines to autism that have been repeatedly disproven by scientific studies. The discussion c…
    STAT · 11d agoNegative↗ source
  • Teva named stalking horse bidder to acquire BioXcel's neuroscience assets for $57.5 million
    BioXcel Therapeutics, a Connecticut biotech focused on neuroscience, filed for Chapter 11 bankruptcy after running out of cash to fund operations through August. In the filing, the company selecte…
    Fierce Biotech · 11d agoDealNeutral↗ source
  • Medicare’s G2211 billing code for relationship-based primary care falls short of expectations
    The Medicare G2211 billing code, added in 2024, lets doctors add $16 to each visit when they provide comprehensive, relationship‑based primary care. It was meant to reward the broader set of servic…
    STAT · 11d agoRegulatoryNegative↗ source
  • Legal scrutiny of Lindsay Clancy case may deter psychiatrists from treating mothers with mental illness
    Psychiatrists and reproductive specialists warn that the high-profile Lindsay Clancy criminal case could have unintended effects on care for mothers with mental illness. The authors acknowledge th…
    STAT · 10d agoNegative↗ source
  • Erasca appoints Charles Fuchs, former Tubulis CMO, as president of research and development
    STAT+ columnist Ed Silverman highlighted a recent personnel change in the pharmaceutical sector. The regular "comings and goings" feature tracks hires, promotions, and departures across the industr…
    STAT · 10d agoNeutral↗ source
  • FDA approves Roivant's oral dermatomyositis drug Lisraya (brepocitinib)
    The U.S. Food and Drug Administration has granted approval to Roivant's drug brepocitinib, which will be sold under the brand name Lisraya. The decision marks the first major regulatory clearance f…
    Endpoints · 11d agoApprovalPositive↗ source
  • Moderna raises $2 billion after Phase 3 success of its algorithm-driven personalized cancer vaccine with Merck
    Moderna announced a $2 billion convertible debt financing, a move that follows the Phase 3 success of its personalized cancer vaccine developed with Merck. The vaccine relies on software that scan…
    STAT · 11d agoPositive readoutPositive↗ source
  • FDA approves Revolution Medicines' first genetic-targeted therapy for advanced pancreatic cancer
    The U.S. Food and Drug Administration has granted approval for a new treatment developed by Revolution Medicines aimed at patients with advanced pancreatic cancer. The therapy is designed to extend…
    STAT · 12d agoApprovalPositive↗ source
  • Moderna and Merck report late-stage success for personalized mRNA cancer vaccine
    Moderna and Merck announced that their personalized cancer vaccine achieved its primary goals in a late-stage clinical trial, sparking enthusiasm across the biotech community. The experimental the…
    STAT · 12d agoPositive readoutPositive↗ source
  • Gilead secures another FDA approval for HIV therapy, bolstering lenacapavir portfolio
    Gilead Sciences announced that the U.S. Food and Drug Administration has approved a new HIV treatment, adding to the company's growing portfolio of antiviral drugs. The approval extends the reach o…
    Endpoints · 11d agoApprovalPositive↗ source
  • Hospitals Mobilize to Challenge $1 Trillion Medicaid Funding Cuts
    Hospital leaders are reacting to a law that will cut nearly $1 trillion in Medicaid funding over the next ten years, prompting a rapid re‑evaluation of their financial models. Lobbyists and execut…
    STAT · 12d agoRegulatoryNegative↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 12d agoDealPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 11d agoApprovalPositive↗ source
  • Fifth Circuit Court rejects pharma industry's challenge to Medicare negotiation rules
    The Fifth Circuit Court of Appeals issued a ruling that ends the pharmaceutical industry's legal effort to overturn Medicare's negotiation framework. The court denied the industry's request, markin…
    Endpoints · 11d agoRegulatoryNegative↗ source
  • Eli Lilly stops disclosing Phase 1 pipeline, prompting mixed reactions
    Eli Lilly announced that it will no longer publicly share details of its Phase 1 drug candidates. The policy shift comes as the company’s GLP-1 product continues to generate the highest sales among…
    Endpoints · 11d agoNeutral↗ source
  • Senator Cassidy's report blames FDA for lax oversight of abortion pill manufacturers
    Senator Bill Cassidy released a report accusing the Food and Drug Administration of failing to tighten restrictions on the abortion pill mifepristone and of lacking transparency in its oversight.…
    STAT · 12d agoRegulatoryNegative↗ source
  • Alnylam’s heart drug outlook dimmed as rival eplontersen fails at ESC Congress
    The European Society of Cardiology Congress in Munich is a focal point for Alnylam Pharmaceuticals as it seeks clarity on the future of its two ATTR-CM programs. Data presented by AstraZeneca and…
    STAT · 12d agoNegative readoutNegative↗ source
  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 12d agoCRLPositive↗ source
  • FDA approves Roivant's brepocitinib for rare autoimmune disease dermatomyositis
    On Thursday the U.S. Food and Drug Administration gave its nod to a new therapy from Roivant Sciences and its subsidiary Priovant. The oral medication, brepocitinib, will be sold under the brand na…
    STAT · 11d agoApprovalPositive↗ source
  • CMS GLP-1 pilot shows early uptake and health benefits for seniors, signaling broader weight-loss drug access
    CMS launched a federal pilot program to expand access to GLP-1 weight-loss medications for seniors. After about two months, early data show that enrollment is rising and participants report improv…
    Endpoints · 11d agoRegulatoryPositive↗ source