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2,285 stories matching this filter · ← front page

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  • England's NHS to fund AstraZeneca's Enhertu for metastatic breast cancer after U.K.-U.S. pricing pact
    English health authorities have agreed to provide AstraZeneca's breast cancer drug Enhertu through the NHS, ending a multi-year dispute over its availability. The decision will make the drug acces…
    STAT · 1mo agoDealPositive↗ source
  • ARPA-H launches SPECTRA program to advance autism diagnosis and precision care
    ARPA-H announced the launch of the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, a new effort aimed at transforming autism diagnosis and precisio…
    Fierce Biotech · 1mo agoRegulatoryPositive↗ source
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  • FDA staffing shortage limits ability to hire new employees, raising concerns for health-care oversight
    STAT's D.C. Diagnosis newsletter reports that the FDA is experiencing a staffing bottleneck, with too few current employees to bring on additional hires. The shortage could slow the agency's capac…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Study finds purer fentanyl will not curb U.S. overdose deaths
    A new study highlighted that increasing the purity of fentanyl is unlikely to lower the number of overdose fatalities in the United States. Researchers noted that while purer fentanyl may be more…
    STAT · 1mo agoNegative↗ source
  • Sellas’ Phase 3 REGAL AML Immunotherapy Study Delayed, Forecast to Miss Survival Endpoint
    Sellas Life Sciences Group’s experimental immunotherapy galinpepimut‑S (GPS) is being tested in a Phase 3 REGAL trial for patients with acute myeloid leukemia in a second remission. The study has b…
    STAT · 1mo agoNegative↗ source
  • Lisata Therapeutics merges with Marea Therapeutics in reverse merger after failed Kuva deal
    Lisata Therapeutics, a solid tumor biotech, announced a stock-for-stock merger with cardiovascular specialist Marea Therapeutics after a previous merger attempt with Kuva Labs collapsed. The trans…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • Rare inherited EGFR mutation raises lung cancer risk 62-fold in never-smokers, 25-fold in smokers
    Researchers examined genotyping data from 23andMe covering 3.37 million individuals and found the T790M germline mutation in about one out of every 15,850 people. The study reported that carriers…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Researchers sue NIH over grant screening that they say violates First Amendment rights
    Researchers have filed a class action lawsuit against the National Institutes of Health, claiming the agency violates their First Amendment rights by searching grant applications for specific words…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Rare genetic variant linked to much higher lung cancer risk in never-smokers
    Researchers have discovered a very rare genetic variant that dramatically increases the odds of developing lung cancer among people who have never smoked. The study, published in Science, reports a…
    STAT · 1mo agoPositive↗ source
  • Goa Therapeutics launches with $15.5M funding to develop fast-acting alcohol sobering drug
    Goa Therapeutics announced its launch, backed by $15.5 million raised mainly from individual industry leaders, and has filed for an initial public offering that could raise up to $75 million. The…
    Fierce Biotech · 1mo agoPositive↗ source
  • Biotech hedge fund launches North Immunology to develop long-acting antibody for atopic dermatitis
    STAT+ hedge fund is creating a new immunology company called North Immunology with the goal of delivering a better, long-acting antibody therapy for atopic dermatitis. The concept originated two y…
    STAT · 1mo agoPositive↗ source
  • FDA hiring drive to add 2,000 staff stalls due to overwhelmed HR center
    The Food and Drug Administration says it plans to bring on more than 2,000 new employees, a move aimed at rebuilding staff after the 2025 cuts that eliminated about 3,500 positions. Agency officia…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • North Immunology to go public via reverse merger, targeting eczema with bispecific antibody
    North Immunology, a private biotech incubated by ADAR1 Capital Management, announced it will become a public company through a reverse merger with Nasdaq‑listed Aethlon Medical. The merged entity…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • 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
  • 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
  • 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
  • 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