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3,403 stories matching this filter · ← front page

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  • 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 · 4mo 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 · 4mo agoRegulatoryNeutral↗ source
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  • 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
  • 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 · 4mo 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 · 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
  • 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 · 4mo 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 · 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
  • 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 · 4mo agoRegulatoryNegative↗ 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
  • 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 · 4mo 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 · 4mo agoNegative readoutNegative↗ source
  • Two biotech firms raise $556 million in combined IPOs
    Seaport Therapeutics and Hemab Therapeutics launched initial public offerings on Thursday, together bringing in $556.4 million to fund further development of their drug pipelines. Hemab Therapeuti…
    BioPharma Dive · 4mo agoDealPositive↗ 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 · 4mo 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 · 4mo 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 · 4mo agoCRLPositive↗ 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