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4,401 stories matching this filter · ← front page

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  • FDA resumes publishing pharma rejection letters, posting 14 new CRLs
    The FDA announced on Friday that it has posted fourteen new complete response letters (CRLs) to pharmaceutical companies on its website. This marks a return to the agency’s regular practice of mak…
    Endpoints · 4mo agoCRLNeutral↗ source
  • Pfizer promotes Danna Breen to lead obesity discovery, succeeding Kendra Bence
    Pfizer announced that Danna Breen has been promoted to head of its obesity discovery program, according to a LinkedIn post. Breen takes over from Kendra Bence and brings nearly 14 years of experie…
    Endpoints · 4mo agoNeutral↗ source
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  • FDA’s drug review center adds over 100 staff in a quarter, first net gain since late 2024
    The FDA’s Center for Drug Evaluation and Research (CDER) reported hiring more than 100 new employees in the most recent quarter. This net increase is the first time the drug center has added more…
    Endpoints · 4mo agoNeutral↗ source
  • Cellular Intelligence hires neurologist to assess Novo Nordisk's Parkinson's stem cell program
    Cellular Intelligence, an AI‑driven biotech, announced it is evaluating Novo Nordisk's Parkinson's stem cell therapy after Novo shut down its cell therapy unit. The company engaged neurologist and…
    Endpoints · 4mo agoDealNeutral↗ source
  • Primary Care Shows Strong Performance Yet Remains Miscast as Health Crisis Solution
    The latest MedPAC report to Congress highlights that primary-care delivery in the United States is performing well by several measures. Nearly all Medicare beneficiaries have a designated primary-c…
    STAT · 4mo agoNeutral↗ source
  • Boston ER doctor Jeremy Faust grows influence with Inside Medicine newsletter
    Jeremy Faust works as an emergency physician at Brigham and Women's Hospital in Boston, handling busy shifts and caring for dozens of patients. In addition to his clinical duties, Faust runs the S…
    STAT · 4mo agoPositive↗ source
  • Boys' Club of New York offers after-school program that supports mental health of at-risk boys
    The Boys' Club of New York, a 150-year-old organization, runs three clubhouses serving about 2,500 middle-school boys from disadvantaged backgrounds. The program provides after-school and weekend…
    STAT · 4mo agoPositive↗ source
  • AstraZeneca shares tumble after heart drug trial fails
    AstraZeneca's stock fell in early trading on Thursday after the company disclosed that its experimental heart disease therapy, developed with Ionis Pharmaceuticals, did not meet primary endpoints i…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Eli Lilly leads biotech M&A in H1, leveraging obesity drug success and trillion-dollar scale
    Eli Lilly, already the largest pharmaceutical company, has emerged as a leading buyer of biotech assets in the first half of 2026. Its trillion-dollar market size and recent successes in obesity t…
    Endpoints · 4mo agoDealPositive↗ source
  • ARPA-H earmarks $160 million for custom gene-editing therapies, sparking debate on adequacy
    ARPA-H announced a $160 million investment to support development of bespoke gene‑editing treatments. This follows a recent case where an infant was rescued from a lethal disease using a personaliz…
    Endpoints · 4mo agoNeutral↗ source
  • AstraZeneca and Ionis see pivotal trial miss for ATTR-CM drug Wainua
    AstraZeneca announced that its experimental therapy Wainua, developed with Ionis, failed to meet primary endpoints in a pivotal study for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). T…
    STAT · 4mo agoNegative readoutNegative↗ source
  • Father spends $70 million on gene therapy trial for daughter with ultra-rare disease, faces FDA hurdles
    Matt Wilsey has spent a decade and about $70 million trying to develop a gene therapy for his 15-year-old daughter Grace, who suffers from a fatal ultra-rare disease. His personal quest has turned…
    STAT · 4mo agoNegative↗ source
  • HHS proposes new rule to compensate Covid-19 vaccine injury claims
    The U.S. Department of Health and Human Services has issued a proposed rule that would create a compensation mechanism for people who say they were injured by Covid-19 vaccines. The new system is…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Roche halts development of Huntington’s disease drug tominersen after ten years of trials
    Roche announced it is stopping work on tominersen, its experimental therapy for Huntington’s disease. The decision follows a Phase 2 study in which the drug performed no better than placebo. The c…
    Endpoints · 4mo agoNegative↗ source
  • UK regulator advises stopping reimbursement for Amgen's lung cancer drug Lumakras for new patients
    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • FDA reprimands Lundbeck Seattle Biopharmaceuticals for inflated claims on Vyepti migraine webpages
    The U.S. Food and Drug Administration issued an untitled letter to Lundbeck Seattle Biopharmaceuticals criticizing two promotional webpages about its migraine treatment Vyepti. The agency said the…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • FDA pauses public release of Complete Response Letters to limit litigation risk
    The FDA announced it has temporarily halted the routine public posting of Complete Response Letters (CRLs), which are letters sent to drug sponsors when the agency does not approve a marketing appl…
    Endpoints · 4mo agoCRLNeutral↗ source
  • Michigan sees nearly 1,000 cyclospora cases, the state's largest outbreak and among the nation's biggest
    Nearly a thousand residents of Michigan have been diagnosed with a cyclospora infection that causes prolonged watery diarrhea, making it the biggest outbreak in the state's history and one of the l…
    STAT · 4mo agoNeutral↗ source
  • ARPA-H launches $160 million THRIVE program to fund seven labs developing custom gene-editing therapies for rare diseases
    ARPA-H, the U.S. Advanced Research Projects Agency for Health, announced a new initiative called THRIVE with up to $160 million in funding. The program will support seven research teams over five…
    STAT · 4mo agoPositive↗ source
  • Ipsen's Dysport shows positive Phase 3 results in migraine, Tarsus acquires iRenix for $75M
    Ipsen reported that its injectable neurotoxin Dysport met the primary endpoint in a Phase 3 trial aimed at reducing monthly migraine days. The trial demonstrated a statistically significant reduct…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Prime Secures Arbitration Victory Over Beam, Paving Way for Clinical Trials
    Prime, a biotech firm developing a gene‑therapy candidate, won an arbitration case against Beam Therapeutics. The ruling removes a legal hurdle and allows Prime to advance its program into clinical…
    STAT · 4mo agoRegulatoryPositive↗ source
  • AstraZeneca/Ionis heart-failure drug Wainua fails pivotal trial as White House reviews FDA commissioner candidates
    The White House is reviewing a shortlist of three candidates for the FDA commissioner position, according to STAT. The list includes White House adviser Heidi Overton, oncologist and health‑system…
    STAT · 4mo agoNegative readoutNegative↗ source
  • Father invests $70 million in gene therapy quest for daughter with ultra‑rare NGLY1 deficiency, faces FDA scrutiny
    Matt Wilsey has spent a decade and roughly $70 million trying to develop a gene therapy for his daughter Grace, who suffers from NGLY1 deficiency, an ultra‑rare genetic disorder. NGLY1 deficiency…
    STAT · 4mo agoRegulatoryPositive↗ source
  • GSK terminates $700 million Alector partnership after recent trial setbacks
    GSK has decided to end its collaboration with Alector, a biotech focused on neurodegenerative diseases. The agreement originally included a $700 million upfront payment. The move follows two high-…
    Endpoints · 4mo agoDealNegative↗ source
  • Northwest Biotherapeutics' brain cancer therapy faces 931-day delay in UK approval
    Northwest Biotherapeutics, a public biotech developing a brain cancer treatment, filed a marketing application with the UK Medicines and Healthcare products Regulatory Agency (MHRA) in late Decembe…
    STAT · 4mo agoRegulatoryNegative↗ source