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  • Celcuity reports positive Phase 3 data for gedatolisib, bolstering broader approval prospects
    Celcuity announced new data from an ongoing Phase 3 trial of its experimental breast cancer drug gedatolisib. The data showed that two- and three-drug combinations that included gedatolisib delaye…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Supreme Court blocks restriction, keeps mifepristone available via telehealth, mail and pharmacies
    The Supreme Court issued an order on Monday that temporarily restores broad access to the abortion medication mifepristone, overturning a recent appellate court ruling that would have limited its d…
    STAT · 4mo agoRegulatoryPositive↗ source
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  • UCB to buy antibody maker targeting autoimmune diseases
    UCB announced it will acquire a company that develops antibody treatments for autoimmune disorders. The deal expands UCB’s pipeline in a therapeutic area where it seeks to strengthen its market pos…
    STAT · 4mo agoDealNeutral↗ source
  • Two drugmakers petition Supreme Court to reinstate mail-order access to abortion pill mifepristone
    Two drugmakers, Danco Laboratories and GenBioPro, have asked the U.S. Supreme Court to restore mail-order distribution of mifepristone, the abortion pill. The request follows a recent appellate co…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Federal appeals court rules mifepristone can only be dispensed in person, blocking mail distribution
    A federal appeals court issued a ruling that mifepristone, the medication used for medical abortions, must be provided only in person at clinics. The decision overturns the FDA regulation that had…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Latus Bio secures $42 million to launch Huntington’s disease gene therapy trial
    Biotech startup Latus Bio announced it has raised $42 million to fund its first clinical trials, including a gene‑therapy program aimed at Huntington’s disease. The capital will be used to seek FDA…
    STAT · 4mo agoDealPositive↗ source
  • AI drug repurposing in oncology hampered by fragmented data, curated knowledge needed
    AI tools are being used to look for new cancer indications for existing biologics, but the article notes that fragmented and disparate data sets limit even the most advanced models. Repurposing pr…
    BioPharma Dive · 4mo agoNeutral↗ source
  • New visa hurdles push foreign PhD scientists to abandon US labs for home-country jobs
    Recent data show a decline in applications from international students and researchers to U.S. labs, as new immigration procedures create uncertainty. The article follows a PhD candidate from Indi…
    STAT · 4mo agoNegative↗ source
  • New study shows AI tools in emergency rooms are being overhyped, experts caution
    A recent analysis of artificial‑intelligence applications in emergency departments concluded that the technology’s impact is far more modest than many headlines suggest. The authors warned that exp…
    STAT · 4mo agoNegative↗ source
  • Study finds fatherhood may lower early mortality, calls for more focus on paternal deaths
    Researchers published a letter in JAMA Pediatrics calling for greater study of paternal deaths, noting that being a father may lower early mortality. The authors cite a pilot study from Georgia th…
    STAT · 4mo agoNeutral↗ source
  • Rodent-borne hantavirus suspected in cruise ship outbreak that killed three and sickened others
    A rodent-borne illness is believed to be behind a recent cruise ship outbreak that has resulted in three deaths and several illnesses, according to health officials. The disease, known as hantavir…
    STAT · 4mo agoNeutral↗ source
  • Experts question the validity of blue zones concept amid new genetic study
    The opinion piece by medical journalist Shelley Wood and cardiologist Eric Topol examines growing doubts about the “blue zones” idea, which originally described a handful of Sardinian villages note…
    STAT · 4mo agoNeutral↗ source
  • Federal Appeals Court Bars Mailing of Abortion Pill Mifepristone, Limits Distribution to Clinics
    A three-judge panel of the 5th U.S. Circuit Court of Appeals issued a unanimous decision that the abortion pill mifepristone may no longer be mailed. The court ordered that the drug be dispensed on…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Medical students voice concerns about nutrition and preventive care training
    First Opinion’s podcast hosted a conversation with two medical students about how their education addresses nutrition and preventive‑care concepts. The discussion comes amid growing political call…
    STAT · 4mo agoNeutral↗ source
  • STAT reader critiques MAHA activism and calls out misinformation in health debates
    A STAT reader responded to an opinion essay that discussed MAHA activists, perimenopause and diversity in medical school. The letter praised the chance to engage with professional experts while not…
    STAT · 4mo agoNegative↗ source
  • Bristol Myers shows modest revenue rise, Biogen beats forecasts, Regeneron outlook remains uncertain
    BioPharma Dive highlighted the latest quarterly earnings from three major biotech firms, noting how investors are interpreting the results. Bristol Myers Squibb reported $11.5 billion in revenue f…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • FDA approves Arvinas' PROTAC drug Veppanu for specific metastatic breast cancer
    U.S. regulators have granted approval for Veppanu, a protein-degrading therapy developed by biotech firm Arvinas, to treat a defined group of patients with metastatic, estrogen-receptor-positive, H…
    BioPharma Dive · 4mo agoApprovalPositive↗ source
  • Summit Therapeutics' ivonescimab misses interim goal, shares tumble 27% as trial setback raises doubts
    Summit Therapeutics reported that its experimental immunotherapy ivonescimab failed to achieve statistical significance at an interim analysis of the late-stage HARMONi-3 trial in frontline non‑sma…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Moderna reports Q1 revenue surge driven by international COVID vaccine sales despite larger net loss
    Moderna posted first‑quarter revenue of $389 million, more than triple the same period a year earlier, primarily from overseas COVID‑19 vaccine sales. The company recorded a net loss of $1.3 billi…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Axsome receives FDA nod for Alzheimer’s agitation treatment
    Axsome announced that the U.S. Food and Drug Administration granted it a nod for a therapy aimed at agitation associated with Alzheimer’s disease, according to the STAT+ report. The decision marks…
    STAT · 4mo agoApprovalPositive↗ source
  • FDA proposes removing obesity and diabetes drug ingredients from compounding substances list
    The U.S. Food and Drug Administration has issued a proposal to remove the active ingredients of widely used obesity and diabetes medicines from the list of substances that can be compounded. The ch…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • FDA drops Casey Means as surgeon general nominee, naming Fox News radiologist Nicole Saphier instead
    FDA withdrew the nomination of Casey Means for surgeon general and appointed Nicole Saphier, a radiologist and Fox News commentator. The switch underscores the administration’s limited sway in the…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Founder launches new biotech to scale personalized medicines after prior venture folded
    Julia Vitarello’s daughter Mila received a custom‑designed therapy for her rare mutation eight years ago, sparking Vitarello’s interest in individualized treatments. Her first company, EveryONE Me…
    STAT · 4mo agoNeutral↗ source
  • Ailux appoints former AstraZeneca executive Maria Belvisi as chief scientific officer
    Ailux announced the hiring of Maria Belvisi as its new chief scientific officer. Belvisi comes from AstraZeneca where she served as senior vice president of research and development for respirator…
    STAT · 4mo agoPositive↗ source
  • US fertility decline sparks debate over policy motives and family support
    The piece highlights growing alarm in the United States about a sustained drop in birth rates, pointing to factors such as costly childcare, unaffordable housing, shaky health‑care access, and the…
    STAT · 4mo agoNegative↗ source