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3,038 stories matching this filter · ← front page

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  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
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  • Senate schedules hearing for FDA nominee as Novo teams with Anthropic on AI drug development
    The Senate has announced a hearing to consider the nominee for the next FDA commissioner, signaling a forthcoming review of the agency's leadership. In parallel, biotech firm Novo has entered a pa…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Kennedy appoints eight specialists to U.S. Preventive Services Task Force, ending year-long vacancy
    Health secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, filling vacancies after the panel had not met for more than a year. The appointees in…
    STAT · 1mo agoNeutral↗ source
  • Startup launches trial of psychedelic-style drug for Parkinson’s symptom
    A new biotech startup announced it will begin preclinical testing of a psychedelic-like compound aimed at alleviating a specific symptom of Parkinson’s disease. The company plans to evaluate the d…
    STAT · 1mo agoNeutral↗ source
  • Shift away from oppositional defiant disorder reflects changing views on child noncompliance
    Lawrence Diller, a behavioral pediatrician, writes about a noticeable shift in how clinicians label children who resist authority. He recounts a recent call from a mother who asked whether her son…
    STAT · 1mo agoNeutral↗ source
  • MHRA AI Commission Issues 44 Recommendations for Future UK Regulatory Framework
    A commission established by the Medicines and Healthcare products Regulatory Agency has released its findings. The group presented 44 recommendations aimed at shaping the United Kingdom’s regulato…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Former FDA chief Califf calls for regulatory overhaul and predicts AI assistants in future oversight
    Robert Califf, who served as FDA commissioner, reflected on his early experience as a medical student in the 1970s working with a pioneering patient database that tracked cardiovascular procedures…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Definium shares new psychedelics data and court reprieve for international researchers discussed on The Readout LOUD
    The latest episode of STAT's "The Readout LOUD" podcast covered two timely topics: Definium's recently released psychedelics data and a court decision that gave international scientists a brief leg…
    STAT · 1mo agoNeutral↗ source
  • FDA hiring delays persist despite expectations, and Bavarian Nordic names new CEO
    The recent discussion about a hiring surge at the U.S. Food and Drug Administration following last year’s DOGE budget cuts has not materialized as expected. Industry observers had anticipated a rap…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Health Secretary RFK Jr. delivers anti‑vaccine keynote at Children’s Health Defense conference
    Robert F. Kennedy Jr., the U.S. health secretary, opened the Children’s Health Defense conference with a keynote that focused on his criticism of vaccines. The speech revisited his broader health…
    STAT · 1mo agoNegative↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Zocdoc adds chatbot scheduling and updates on Medicare ACCESS
    Zocdoc announced that its platform now lets users book medical appointments directly through chatbots and health‑plan websites. The new integration means patients can schedule visits without leavi…
    STAT · 1mo agoNeutral↗ source
  • Health secretary Kennedy launches program to accelerate autism diagnosis
    U.S. health secretary Robert F. Kennedy Jr. announced a new initiative aimed at speeding up autism assessments during a keynote at a Children’s Health Defense conference. He said the existing diag…
    STAT · 1mo agoPositive↗ source
  • STAT+: FDA approves a new gene therapy for Sanfilippo syndrome, an ultra-rare disease
    The FDA approved a new gene therapy for Sanfilippo syndrome type A, an ultra-rare disease sometimes known as childhood Alzheimer’s.
    STAT · 1mo ago↗ source
  • Novo signs $1.4 billion deal with Orbis Medicines to develop oral macrocycle cardiometabolic drugs
    Novo, which recently rebranded from Novo Nordisk, announced a partnership with Copenhagen‑based Orbis Medicines. The agreement could provide up to $1.4 billion in upfront payments and milestone pay…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Novartis halts ALS drug VHB937 after phase 2 trial fails to meet endpoints
    Novartis announced it is stopping development of its ALS candidate VHB937 after the phase 2 Astrals trial did not meet its primary or secondary endpoints. The study enrolled 251 patients with earl…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • Stanford researchers create mice with half human brain tissue using cerebral organoids
    Scientists at Stanford have implanted human cerebral organoids into mice whose own brain regions were genetically removed, producing neuro-chimeric animals whose brains are about half human by volu…
    STAT · 1mo agoNeutral↗ source
  • U.S. sees highest number of measles deaths in decades as outbreak spreads to 693 cases
    The United States has recorded four measles-related deaths so far in 2026, the highest number of deaths from the disease in any year since 1992. The deaths occurred in Pennsylvania, where the outb…
    STAT · 1mo agoNeutral↗ source
  • Senator Todd Young urges White House to appoint biotech leader amid rising Chinese innovation
    Senator Todd Young, chair of the National Security Commission on Emerging Biotechnology, told Fierce he is concerned about China’s expanding role in biopharma. The commission notes that Chinese co…
    Fierce Biotech · 1mo agoRegulatoryNegative↗ source
  • Novartis pays $125 million to acquire Sironax’s brain-delivery platform
    Novartis has exercised an option to buy Sironax’s platform for delivering large molecules across the blood‑brain barrier, with a $125 million payment due at closing. The technology is intended to…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Dementia should be a campaign issue, not a political insult, says expert
    Jason Karlawish, a professor at Penn and co‑director of the Penn Memory Center, argues that dementia deserves serious policy focus during the upcoming election. He notes that about 7.1 million Ame…
    STAT · 1mo agoNeutral↗ source
  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • GOP Bill Seeks to Tilt Medicare Advantage Study Toward Insurers
    Republicans on the House Ways and Means Committee advanced a bill that would direct the Medicare Payment Advisory Commission, MedPAC, to study Medicare Advantage spending in a way that favors insur…
    STAT · 1mo agoRegulatoryNegative↗ source