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205 stories matching this filter · ← front page

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  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 7h agoNegative readoutNegative↗ source
  • Novo Nordisk's late-stage anti-inflammatory heart drug fails Phase 3 trial
    Novo Nordisk announced that its experimental anti-inflammatory compound designed to target cardiovascular inflammation did not meet its primary endpoint in a Phase 3 trial. The study was intended…
    Endpoints · 7h agoNegative readoutNegative↗ source
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Infectious Disease253
Nephrology239
  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 10h agoNegative readoutNegative↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 1d agoEarningsNegative↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 1d agoPositive readoutPositive↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 1d agoRegulatoryNegative↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 2d agoEarningsPositive↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 2d agoRegulatoryNegative↗ source
  • FDA advisory panel advises against approving Capricor’s Duchenne cell therapy, deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee convened to evaluate deramiocel, a cell‑based treatment for Duchenne muscular dystrophy developed by Capricor Therapeutics. Capricor…
    STAT · 2d agoRegulatoryNegative↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 3d agoRegulatoryNeutral↗ source
  • ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions
    The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…
    STAT · 2d agoNegative↗ source
  • STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
    Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
    STAT · 4d agoRegulatoryNeutral↗ source
  • STAT+: Fatal gene-editing trial in China raises ethics and oversight questions
    Sanofi insulin pen in short supply, a win for peptide compounds, and more biotech news from The Readout
    STAT · 7d ago↗ source
  • American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
    July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consume…
    fda recalls · 7d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 8d ago↗ source
  • FDA panel confronting peptide controversy
    Today's biotech news features the FDA weighing the fate of peptides; approvals for RevMed, GSK; and data on Lilly's "triple-G."
    STAT · 8d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Lilly obesity drug data, a push for FDA to ban DTC ads, and more
    A study of Lilly's retatrutide weight loss drug in people with heart disease did not answer a crucial question — whether it reduces cardiovascular risk
    STAT · 8d ago↗ source
  • STAT+: New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit
    On analyses that looked at major cardiovascular events, those taking retatrutide did not have a significant lower risk of death, heart attack, or stroke.
    STAT · 8d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 9d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 9d ago↗ source
  • Opinion: STAT+: I’m a cardiologist. I’m not sure the new cholesterol drug enlicitide is a game-changer
    “In truth, I don’t anticipate prescribing patterns changing immediately,” cardiologist Vishal Khetpal writes of the new cholesterol drug Lipfendra.
    STAT · 9d ago↗ source
  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    BioPharma Dive · 10d ago↗ source
  • Pain drugmaker Latigo outlines plans to go public
    The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.
    BioPharma Dive · 11d ago↗ source
  • HHS vaccine committee quietly gets new charter
    Lax clinical oversight for online GLP-1 prescriptions, proposed financial help for people who want to quit smoking, and more health news
    STAT · 11d ago↗ source
  • Opinion: My husband’s suicide shows there’s something very wrong with the U.S. insurance industry
    “My love for Randy and my professional experience were not enough to save him,” a physician writes about her husband’s suicide.
    STAT · 11d ago↗ source