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4,401 stories matching this filter · ← front page

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  • 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 · 6mo 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 · 6mo agoRegulatoryNegative↗ source
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  • Swiss biotech Windward Bio raises $165 million to launch Phase 3 asthma trial for China-derived drug
    Swiss biotech Windward Bio announced it has secured $165 million in financing. The capital will be used to move one of its two experimental medicines, originally discovered in China, into a Phase…
    Endpoints · 6mo agoDealPositive↗ 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 · 6mo agoDealPositive↗ source
  • Vertex halts mRNA cystic fibrosis program citing tolerability concerns
    Vertex Pharmaceuticals announced it is ending development of its mRNA-based cystic fibrosis therapy after encountering tolerability problems that echo challenges seen elsewhere in the field. The B…
    Endpoints · 6mo agoNegative↗ source
  • FDA narrows search for new CBER chief to three or four finalists
    The FDA announced that its search for a new head of the Center for Biologics Evaluation and Research (CBER) has been narrowed. According to a source familiar with the process, the agency is now fo…
    Endpoints · 6mo agoRegulatoryNeutral↗ 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 · 6mo agoNegative↗ source
  • Biotech sees rise of lean startups backed by large funding and Chinese assets
    A new wave of biotech companies is emerging that prioritises lean organizational structures over extensive early‑stage research programs. These firms are being launched with modest employee counts…
    Endpoints · 6mo agoNeutral↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoRegulatoryNegative↗ source
  • Bristol Myers faces pivotal year as Q1 earnings season begins
    The weekly Endpoints newsletter for the last week of April highlighted that several pharmaceutical companies released their first-quarter earnings. Among them, Bristol Myers was singled out as bei…
    Endpoints · 6mo agoEarningsNeutral↗ 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 · 6mo 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 · 6mo agoNegative↗ source
  • Purdue Pharma to dissolve after judge confirms criminal sentence tied to opioid settlement
    A federal judge approved a criminal sentence for Purdue Pharma, clearing the final hurdle for a massive settlement that will resolve thousands of lawsuits related to the opioid crisis. The judge h…
    STAT · 6mo agoRegulatoryNegative↗ source
  • FDA approves Axsome Therapeutics' Auvelity for Alzheimer’s agitation
    The U.S. Food and Drug Administration has granted approval to Axsome Therapeutics’ oral medication Auvelity for the treatment of agitation in patients with Alzheimer’s disease. Axsome noted that a…
    Endpoints · 6mo agoApprovalPositive↗ source
  • Summit Therapeutics shares tumble 20% after interim Phase 3 miss for ivonescimab
    Summit Therapeutics saw its shares fall about 20% after the market close on Thursday. The decline came after an interim analysis of a Phase 3 trial for its cancer candidate ivonescimab failed to m…
    Endpoints · 6mo agoNegative readoutNegative↗ source
  • Moderna discusses post-marketing data with FDA to expand Covid-19 vaccine label
    Moderna announced it is working with US regulators to supply post-marketing data on its Covid-19 vaccines. The effort aims to address the FDA's decision last year to narrow the vaccine label, limi…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • FDA greenlights Pfizer/Arvinas breast cancer therapy vepdegestrant despite modest trial results
    The U.S. Food and Drug Administration announced approval of vepdegestrant, a therapy developed by Pfizer and Arvinas, for a specific subtype of breast cancer. The decision comes even though the cl…
    Endpoints · 6mo agoApprovalNeutral↗ source
  • Amgen initiates three late-stage trials of obesity shot MariTide, including a switch-patient study
    Amgen announced the start of three new Phase 3 trials for its long-acting obesity injection, MariTide. One of the studies will enroll participants who are transitioning away from the GLP-1 therapi…
    Endpoints · 6mo agoCRLPositive↗ 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 · 6mo 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 · 6mo agoRegulatoryNeutral↗ source
  • Seaport and Hemab price IPOs as Avalyn soars on Nasdaq debut
    Three biotechnology companies announced the pricing of their initial public offerings between Thursday and Friday, collectively targeting more than $850 million in proceeds. Seaport Therapeutics a…
    Endpoints · 6mo agoDealPositive↗ source