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2,591 stories matching this filter · ← front page

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  • Democrats eye key House committees as midterms approach, opening doors for new health policy influence
    Dozens of Democrats are competing for seats on the House Energy and Commerce and Ways and Means committees as they anticipate winning back control of the chamber. Several incumbents from both part…
    STAT · 12d agoRegulatoryNeutral↗ source
  • Vir Biotechnology appoints David Liu as chief medical officer to steer hepatitis D phase 3 and cancer programs
    Vir Biotechnology announced the appointment of David Liu, M.D., Ph.D., as its new chief medical officer. Liu comes from a recent stint as CMO at Nuvation Bio and has held senior roles at AstraZene…
    Fierce Biotech · 12d agoNeutral↗ source
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  • All 2026 Nobel laureates in science are men, highlighting ongoing gender gap
    The Nobel committees announced this year’s winners in physiology or medicine, physics and chemistry, and every recipient was male. Women have accounted for roughly 4% of laureates since the awards…
    STAT · 12d agoNegative↗ source
  • AI tool for breast cancer risk moves to direct-to-consumer amid regulatory scrutiny of Utah sandbox
    A startup featured in STAT's Health Tech newsletter is launching its breast cancer risk prediction algorithm directly to patients, bypassing traditional clinical pathways. The direct-to-consumer r…
    STAT · 12d agoNeutral↗ source
  • Democrats compete for new seats on House Energy and Commerce and Ways and Means committees after midterms
    Washington reporters note that the House Energy and Commerce and Ways and Means committees are likely to welcome several new members following the 2026 midterm elections. A combination of a potent…
    STAT · 12d agoNeutral↗ source
  • Mother and daughter seek community for ultra-rare Nicolaides-Baraitser syndrome
    In October 2020 a pediatric geneticist diagnosed an 11‑year‑old girl, Maya, with Nicolaides‑Baraitser syndrome, a condition documented in only 61 cases in the scientific literature. The doctor war…
    STAT · 12d agoNeutral↗ source
  • Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 13d ago↗ source
  • Cerevance's solengepras cuts OFF time in phase 3 Parkinson's trial
    Cerevance reported that its oral non‑dopaminergic therapy, solengepras, produced meaningful improvements in both motor and non‑motor symptoms in a phase 3 Parkinson's disease study, rescuing the ca…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Optogenetics therapy restores light sensitivity in half of retinitis pigmentosa patients in early trial
    A small clinical study examined an optogenetics‑based approach for treating retinitis pigmentosa, a genetic disorder that progressively destroys retinal light‑sensing cells and often leads to legal…
    STAT · 13d agoPositive readoutPositive↗ source
  • Cadrenal Therapeutics launches strategic review to explore sale or partnership for its late-stage cardiology pipeline
    Cadrenal Therapeutics, a heart-focused biotech, announced a strategic review of its late-stage cardiology pipeline, seeking to offload assets or the entire company. The board is evaluating options…
    Fierce Biotech · 13d agoDealNegative↗ source
  • 2026 Nobel Chemistry Prize honors research on chiral molecules with implications for drug development
    Henri B. Kagan, 95, and Kenso Soai, 76, received the 2026 Nobel Prize in chemistry for their work on asymmetric organic synthesis. Their research uncovered how certain reactions can act as their o…
    STAT · 13d agoPositive↗ source
  • Matchpoint Therapeutics raises $150M Series B to advance oral covalent therapies for autoimmune disease
    Matchpoint Therapeutics announced a $150 million Series B financing round. The round was co-led by Nextech Invest and Norwest, with participation from Sanofi Ventures, Digitalis Ventures, Invus, BB…
    Fierce Biotech · 13d agoDealPositive↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 14d agoRegulatoryNeutral↗ source
  • Trump administration proposes $70,000 fee for OPT program, raising concerns for biotech talent pipeline
    The Department of Homeland Security announced a proposal to charge $70,000 for the Optional Practical Training (OPT) program, which allows international students on F-1 visas to work in the United…
    STAT · 13d agoRegulatoryNegative↗ source
  • PhRMA sues Trump administration over Medicare GLOBE price pilot
    PhRMA filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's GLOBE pilot that would tie Medicare Part B drug prices to those in peer nations.…
    STAT · 13d agoRegulatoryNegative↗ source
  • Dutch court blocks Merck's subcutaneous Keytruda in several European markets
    A Dutch court has ruled that Merck infringed a patent covering a subcutaneous formulation of its cancer drug Keytruda. The decision requires the company to stop manufacturing and marketing that ver…
    STAT · 13d agoRegulatoryNegative↗ source
  • Forbion secures $2.6 billion in its biggest European venture fund to date
    Forbion, a leading European venture capital firm, announced it has closed a $2.6 billion fund, the largest it has raised and among the biggest recent funds in the region. The new capital will be d…
    STAT · 13d agoDealPositive↗ source
  • DOJ expands fraud enforcement to include drug and device makers under FD&C Act
    The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act. In…
    STAT · 13d agoRegulatoryNegative↗ source
  • ARPA-H launches Surpass program to speed and broaden clinical trials
    The U.S. Department of Health and Human Services announced a new initiative called Surpass, aimed at removing obstacles that slow clinical development and changing how trials are designed and run.…
    Fierce Biotech · 13d agoPositive↗ source
  • TCGX raises $600 million to fund Asian biotech startups
    Investment firm TCGX announced a new $600 million Asia Life Sciences Fund I aimed at supporting biotech companies across the region. The fund will operate separately but in close coordination with…
    Fierce Biotech · 13d agoDealPositive↗ source
  • Atsena reports early efficacy signals for gene therapy ATSN-201 in X-linked retinoschisis trial
    Atsena Therapeutics presented data from the early parts of its Lighthouse gene therapy trial for X-linked retinoschisis (XLRS) at the American Academy of Ophthalmology meeting. The trial administe…
    Fierce Biotech · 13d agoPositive readoutPositive↗ source
  • Experimental exon-skipping drug from Avidity Biosciences shows early improvement in a Duchenne patient
    A recent story follows two teenage boys living with Duchenne muscular dystrophy, a rare and fatal muscle‑wasting condition. While one boy’s health continues to decline, the other, a 12‑year‑old nam…
    STAT · 13d agoPositive↗ source
  • Caribou Biosciences shuts down after failing to fund late-stage CAR-T lymphoma trial
    Caribou Biosciences, a biotech co-founded by Nobel laureate Jennifer Doudna, announced it is shutting down. The closure follows the company's inability to raise the funding required for a Phase 3…
    STAT · 13d agoNegative↗ source
  • Stryker appoints Spencer Stiles as CEO, Kevin Lobo to become Executive Chair
    Stryker announced a leadership change, naming Spencer Stiles as the new chief executive officer. Stiles, who has been president and COO, will also join the board. Kevin Lobo, who has led the compa…
    Fierce Biotech · 14d agoNeutral↗ source
  • Utah health AI pilots face regulatory uncertainty as FDA scrutiny looms
    Utah has launched an AI sandbox that allows health-focused artificial-intelligence projects to be tested in real-world settings. The initiative aims to accelerate innovation while monitoring safety…
    STAT · 13d agoRegulatoryNeutral↗ source