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1,151 stories matching this filter · ← front page

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  • GSK lung cancer drug gets speedy approval following $10.6B deal
    The clearance is GSK’s first for a lung cancer medicine and the latest step forward in a yearslong push by the British drugmaker into oncology.
    BioPharma Dive · 8d ago↗ source
  • FDA swiftly puts Makary era in the rearview mirror
    As the White House mulls a pick to lead the FDA, the Trump administration has been washing away the mark of former Commissioner Marty Makary, in a refresh that includes everything from reconsidered…
    Endpoints · 8d ago↗ source
  • Former FDA cancer chief Pazdur says the agency should restructure
    Richard Pazdur, who spent more than two decades leading the FDA’s cancer drug reviews, said the agency has a “golden opportunity” to restructure after being struck last year by the Trump administra…
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Endpoints · 8d ago
↗ source
  • FDA approves Nuvalent's cancer drug, a week after GSK closed $10.6B buyout
    GSK's $10.6 billion acquisition of Nuvalent is delivering surprisingly early results. The FDA on Wednesday approved one of Nuvalent's lung cancer medicines two months earlier than projected, and th…
    Endpoints · 8d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 8d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
    BioPharma Dive · 8d ago↗ source
  • Arrowhead’s gene silencer competitive with Ionis’ in triglyceride disease
    Arrowhead Pharmaceuticals’ lipid-lowering drug has hit in two late-stage trials that could expand its use into a much wider population. Data shared Wednesday showed that Arrowhead’s gene silencer R…
    Endpoints · 8d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    While the possibility of levies on branded pharmaceuticals have had a limited impact on drugmaker revenues, tariffs of up to 200% on copycat medicines could — depending on the specifics — prove mor…
    BioPharma Dive · 8d ago↗ source
  • NIH joins Trump’s $5B AI mission with biomedical research push
    The U.S. Department of Health and Human Services announced new efforts Wednesday aligned with President Donald Trump’s artificial intelligence-driven Genesis Mission. The centerpiece of HHS’ partic…
    Fierce Biotech · 8d ago↗ source
  • Mentari adds $200M to migraine mission; Royalty's latest ATTR-CM deal
    Another $200M for Mentari: Migraine drug developer Mentari Therapeutics has lined up a second private placement as it works to close its reverse merger with InMed Pharmaceuticals. The Paragon Thera…
    Endpoints · 8d ago↗ source
  • Q&A: Lilly returns to neuropsych and looks ahead to Alzheimer's prevention
    LONDON — Eli Lilly, the world’s biggest drugmaker, appears to be getting more ambitious about tackling brain diseases. Last week, the company announced it would pay $2.8 billion upfront to acquire…
    Endpoints · 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 · 8d ago↗ source
  • FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food
    The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.
    fda press · 8d ago↗ source
  • Crystalys gets $130M to take Sobi-rivaling gout drug to market
    A San Diego biotech has raised an additional $130 million to get a gout drug that's already approved in Japan and China onto the US and European markets. Crystalys Therapeutics reeled in the Series…
    Endpoints · 8d 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 · 8d ago↗ source
  • Summit reports two-year survival data for Western patients, though context lacking
    Summit Therapeutics unveiled additional follow-up data on its experimental cancer drug ivonescimab, and how its benefit compares between Asian and Western patients. But key context remains unknown.…
    Endpoints · 8d ago↗ source
  • Celldex scraps antibody in prurigo nodularis after Phase 2 flop
    Celldex said on Tuesday it will stop investigating its mast cell-targeting monoclonal antibody in a type of chronic itch disease after it failed on all efficacy measures in a mid-stage trial. Topli…
    Endpoints · 8d ago↗ source
  • Biopharma dealmaking in 2026: The recovery gathers speed in Q2
    It’s always darkest before the biotech dawn, and at no time was that more true than last summer, as biotech was experiencing a crisis of confidence. We tracked an industry-wide downturn in expectat…
    Endpoints · 8d ago↗ source
  • House passes bill directing FDA to update animal testing rules
    The U.S. House of Representatives passed the FDA Modernization Act 3.0 this week, and lawmakers and animal welfare advocates are celebrating the bill as a step toward a new era in preclinical testi…
    Fierce Biotech · 8d ago↗ source
  • Vertex was only bidder for Crinetics in year's second-highest M&A premium
    To gain control of Crinetics Pharmaceuticals, Vertex Pharmaceuticals was willing to pay the second-highest premium so far in biopharma's banner year for M&A. And the Boston drugmaker was bidding ag…
    Endpoints · 8d ago↗ source
  • Royalty Pharma pens $425M deal for slice of sales on AstraZeneca’s ATTR drug
    Royalty Pharma has secured a stake in another transthyretin-mediated amyloidosis drug, this time paying $125 million upfront to Neurimmune for a cut of the sales of its AstraZeneca-partnered med.
    Fierce Biotech · 8d ago↗ source
  • Celldex ends skin disease program after failing phase 2 test
    A phase 2 study of Celldex’s barzolvolimab in a chronic skin disease has missed its primary endpoint, driving the biotech to end development in the indication and raising doubts about an upcoming e…
    Fierce Biotech · 9d ago↗ source
  • Trump pledges new tariffs on generic drugs not made in the US
    President Donald Trump on Tuesday evening said he will impose up to 200% tariffs on generic drugs sold in the US, if companies do not manufacture those medicines in America. Trump said that for the…
    Endpoints · 9d ago↗ source
  • Novo sues Lilly over 'deceptive' ads comparing GLP-1 drug doses
    The two biggest players in the obesity market are headed to court. Novo Nordisk sued Eli Lilly on Tuesday over what it claims are “maliciously and deceptively false” ads comparing the highest doses…
    Endpoints · 9d ago↗ source
  • ‘We’re moving quickly’: Startup bags rare disease drug as Thiel-backed CEO eyes $50M fundraise
    A rare disease startup with a mission to repurpose proven drugs has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
    Fierce Biotech · 9d ago↗ source