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240 stories matching this filter · ← front page

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  • FDA approves Bayer’s Sunharbo, first Factor XIa inhibitor to lower stroke recurrence risk
    The Food and Drug Administration has approved Bayer's new medication intended to prevent another stroke in patients who have already experienced one. The drug, sold under the brand name Sunharbo,…
    STAT · 14h agoApprovalPositive↗ source
  • FDA warns GLP-1 weight-loss drugs may cause rare eye stroke condition
    The Food and Drug Administration issued a warning that GLP-1 drugs used for weight loss may be linked to a rare eye condition called non-arteritic anterior ischemic optic neuropathy, sometimes desc…
    STAT · 20h agoRegulatoryNegative↗ source
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globenewswire health73
fda press59
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Psychiatry & CNS1197
Ophthalmology1035
Endocrinology & Metabolism774
Pain768
Nephrology758
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 16h agoRegulatoryNeutral↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 19h agoNeutral↗ source
  • AI chatbots may help men share emotions, study suggests
    AI chatbots are not therapists, but they can offer a low‑pressure space where men feel less judged when discussing personal concerns. The article follows Luca, who drove across Europe to be with h…
    STAT · 1d agoNeutral↗ source
  • Recon: FDA orders new eye risk warnings for Ozempic, Zepbound; FDA launches investigation of Novartis’ Zolgensma after cancer ca...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 1d ago↗ source
  • Newly elected scientists aim to restore health equity programs cut by Trump administration
    Two newly elected officials with scientific credentials, Michigan Senator-elect Abdul El-Sayed, an epidemiologist, and Georgia Rep-elect Jasmine Clark, a microbiologist, are preparing to join Congr…
    STAT · 3d agoPositive↗ source
  • Kratom use rises as health officials warn of addiction risk and push emergency bans
    Kratom, a plant‑derived supplement, is becoming more visible in smoke shops and gas stations, yet most Americans remain unfamiliar with the product. Health officials have highlighted the addiction…
    STAT · 4d agoRegulatoryNegative↗ source
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 4d agoApprovalPositive↗ source
  • Revolution Medicines' Rasonque generates $198 million in sales within five weeks of U.S. approval
    Revolution Medicines reported that its pancreatic cancer therapy Rasonque has achieved $198 million in revenue in the first five weeks after receiving U.S. approval. The company said more than 5,00…
    STAT · 4d agoApprovalPositive↗ source
  • New treatments for preeclampsia move closer to patients
    Emily Chaddock’s experience highlights the danger of severe preeclampsia, a pregnancy complication that can threaten both mother and baby. At 27 weeks she developed the condition, leading to a rapi…
    Endpoints · 4d agoPositive↗ source
  • Cloudbreak Pharma’s Phase 3 Eye Drop Shows Significant Benefit in Pterygium Trial
    Cloudbreak Pharma reported that its phase 3 trial of CBT-001, a multi‑kinase inhibitor eye drop for pterygium, met both co‑primary endpoints. The study compared two doses of CBT-001 given twice da…
    Fierce Biotech · 5d agoPositive readoutPositive↗ source
  • Minghui licenses sub-q TED drug to Japan's ASKA in up to $440 million deal
    Minghui Pharmaceutical of China has signed a licensing agreement with Japan's ASKA Pharmaceutical, granting exclusive rights to develop and sell its late‑stage thyroid eye disease (TED) candidate i…
    Fierce Biotech · 6d agoDealPositive↗ source
  • Democrats win Congress and doctors secure key seats, shifting health policy direction
    The recent midterm elections gave Democrats control of both the House and the Senate. Voters also elected a number of doctors and scientists to key congressional positions. These outcomes signal a…
    STAT · 6d agoRegulatoryPositive↗ source
  • Minghui Pharma sells Japanese rights to its Phase 3 thyroid eye disease drug for $110 million upfront
    Minghui Pharmaceutical, a Shanghai‑based biotech, has agreed to transfer the Japanese commercial rights for its late‑stage thyroid eye disease candidate to a specialty pharmaceutical company. The…
    Endpoints · 6d agoDealPositive↗ source
  • Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer study
    Spyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…
    Endpoints · 5d agoNegative readoutNegative↗ source
  • nPhase secures $30M Series D to grow AI-driven clinical data platform
    CRO nPhase announced it has closed a $30 million Series D financing round. The capital will be directed toward expanding its AI-native clinical data platform that debuted in September, which aims t…
    Fierce Biotech · 6d agoDealPositive↗ source
  • American expatriate in Malta finds free health care but misses digital patient portal
    Mariska Breland, an American co‑founder of The Neuro Studio, moved to Malta seeking free health care and recounts her first visit to a local general practitioner. She describes a modest clinic wit…
    STAT · 6d agoNeutral↗ source
  • Physician finds meditation boosts resilience and patient care after intense trauma cases
    The author, an ophthalmologist at Legacy Devers Eye Institute, attended a meditation retreat in the Santa Cruz Mountains last fall. He describes staying awake through dawn as part of the retreat,…
    STAT · 7d agoPositive↗ source
  • Washington resident dies after bird flu infection linked to dairy cattle exposure
    A resident of Yakima County, Washington, died from complications of avian influenza after being exposed to infected cattle at a dairy farm. Health officials said the infection was the H5N1 strain,…
    STAT · 7d agoNegative↗ source
  • Women travel abroad for unproven three-parent IVF marketed to older patients
    STAT investigators found that women are journeying thousands of miles to undergo a mitochondrial‑replacement IVF procedure that is promoted as a fertility option for older patients, even though the…
    STAT · 8d agoNegative↗ source
  • STAT+: Pharmalittle: We’re reading about AstraZeneca cost-cutting, Sun Pharma facility problems, and more
    AstraZeneca has launched a three-year cost-cutting program that aims to slice off $1.5 billion a year, with the savings reinvested in R&D.
    STAT · 10d agoRegulatoryNeutral↗ source
  • 1834 measles letter highlights historic roots of today's anti-vaccine sentiment
    Jim Downs, a medical historian, examined a 1834 letter from Jane Butt in a London journal while at Yale's medical library, noting the date matches 192 years later. Butt described a measles outbrea…
    STAT · 11d agoNeutral↗ source
  • FDA approves Stada's Lucentis biosimilar; Lilly claims its triple-G candidate outperforms Ozempic in diabetes
    The U.S. Food and Drug Administration has granted approval for Stada's biosimilar version of Lucentis, expanding treatment options for eye diseases. Lilly announced that its experimental "triple‑G…
    raps · 12d agoApprovalPositive↗ source
  • Eli Lilly consolidates US and international sales under new global markets unit as veteran exec retires
    Eli Lilly announced that long‑time executive Patrik Jonsson will retire after 36 years with the company. Jonsson has been serving as executive vice president and president of Lilly International, o…
    Fierce Biotech · 11d agoNeutral↗ source