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2,159 stories matching this filter · ← front page

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  • 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 · 1mo 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    The National Institute for Health and Care Excellence (NICE) in the United Kingdom released draft guidance recommending that government reimbursement for Amgen’s lung cancer therapy Lumakras be dis…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 · 1mo agoRegulatoryNegative↗ source
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  • 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo agoRegulatoryNegative↗ source
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • New OpenEvidence study shows it outperforms general-purpose LLMs in health-tech research
    A recent study funded by OpenEvidence compared its platform to general-purpose large language models (LLMs) in health technology research and concluded that OpenEvidence delivered more accurate and…
    STAT · 1mo agoPositive↗ source
  • White House reviews three candidates to lead the FDA
    STAT+ reports that the White House is currently evaluating three leading candidates to become the next head of the Food and Drug Administration. The review process is part of the administration's e…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Mid-year roundup highlights top health-tech trends in 2026
    The editorial team notes that the first half of 2026 has been unusually active for health technology. Five major developments have been identified as the most significant so far. One clear theme i…
    Endpoints · 1mo agoNeutral↗ source
  • Catalent to sell its Nottingham oral solid dose facility to CDMO Codis
    Catalent announced it will divest its United Kingdom manufacturing site, selling the oral solid dose factory located in Nottingham. The buyer is Codis, a contract development and manufacturing org…
    Endpoints · 1mo agoDealNeutral↗ source
  • Doctors urge safe medical cannabis use as more seniors turn to marijuana
    Older adults are becoming the fastest‑growing segment of medical cannabis patients, according to the author, an addiction specialist at Massachusetts General Hospital. He recounts a recent inciden…
    STAT · 1mo agoNeutral↗ source
  • Experts question commercial motives behind labeling obesity as a disease
    Max Moser, a psychology researcher at University College London, argues that calling obesity a disease gives comfort to some patients but also creates a commercial dynamic for drugmakers. Companie…
    STAT · 1mo agoNegative↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Podcast discusses health insurance costs, whistleblower case, and potential FDA commissioner picks
    The Readout LOUD podcast episode explores why employer-provided family health insurance can be as expensive as a new car. The hosts interview a whistleblower who challenged an insurance contractor…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Health officials discuss screen-time harms at Great American State Fair's MAHA Monday
    The Great American State Fair in Washington concluded its two‑week run with a second “MAHA Monday,” a program highlighting the Make America Healthy Again initiative. STAT reporters Alex Hogan and…
    STAT · 1mo agoNeutral↗ source
  • Prime Medicine clears legal hurdle with Beam Therapeutics, moves AATD gene therapy toward clinic
    Prime Medicine announced it will advance its AATD gene editing candidate into clinical trials after arbitrators ruled in its favor in a dispute with Beam Therapeutics. The dispute centered on a 20…
    Endpoints · 1mo agoPositive↗ source
  • White House conducts final review of three candidates for FDA commissioner
    The White House is completing its final review of candidates to become the next Food and Drug Administration commissioner. The shortlist features Heidi Overton, a current White House adviser; Jeff…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • U.S. officials urge pharma companies to increase domestic production of essential generic drugs
    At a private gathering in the Eisenhower Executive Office Building, senior officials from the Trump administration met with pharmaceutical leaders. Secretary of State Marco Rubio, Health Secretary…
    STAT · 1mo agoRegulatoryNeutral↗ source