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464 stories matching this filter · ← front page

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  • AbiVax falls as safety worries cloud ‘landmark’ immune drug results
    A handful of cancer cases reported among treatment recipients overshadowed efficacy results analysts described as “best-in-disease” and sent shares down more than 30%.
    BioPharma Dive · 1mo ago↗ source
  • ASCO ‘26: Bispecifics vs. ADCs, a ‘RAS’ revolution and a step change in prostate cancer
    At the year’s biggest cancer meeting, a high-stakes clash between two popular drug classes erupted, and scientists made headway against a once-insurmountable foe.
    BioPharma Dive · 1mo ago↗ source
  • Why US-manufactured pharmaceutical packaging equipment matters
    As manufacturers modernize operations, the origin of their equipment is a strategic consideration.
    BioPharma Dive · 1mo ago
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↗ source
  • RallyBio tries again for reverse merger, this time with Avenzo
    It's the second attempt for the rare disease company, which initially announced plans to merge with Candid Therapeutics before the immune drug developer was bought by UCB.
    BioPharma Dive · 1mo ago↗ source
  • Servier buys into muscular dystrophy with potentially $2.7B deal
    The French drugmaker has agreed to acquire an experimental tablet from Edgewise Therapeutics that some bullish analysts say could eventually hit peak sales of over $2 billion.
    BioPharma Dive · 1mo ago↗ source
  • 2026 Orphan Drugs Report: A safe(r) passage amid stormy waters?
    Orphan drugs remain commercially durable, strategically relevant and supported by a strong pipeline
    BioPharma Dive · 1mo ago↗ source
  • Akeso, Summit drug extends survival in closely watched lung cancer trial
    Though ivonescimab reduced the risk of death by one-third compared to chemotherapy in a China-based study, the total survival benefit of four months stirred debate and pressured company shares.
    BioPharma Dive · 2mo ago↗ source
  • ‘Unprecedented’ Revolution data point to paradigm shift in pancreatic cancer
    Highly anticipated data presented at ASCO confirmed what’s been heralded as a medical breakthrough against a historically tough-to-treat tumor.
    BioPharma Dive · 2mo ago↗ source
  • At ASCO, Merck makes case for a ‘cornerstone’ cancer drug
    Study results accrued so far are giving Merck greater conviction that the therapy, licensed from a China-based biotech, was worth placing into a sprawling Phase 3 program.
    BioPharma Dive · 2mo ago↗ source
  • Bristol Myers unveils data for one of its next-gen blood cancer drugs
    Called mezigdomide, the drug is one of two protein-degrading medicines Bristol Myers hopes to soon position as successors to its lucrative Revlimid franchise.
    BioPharma Dive · 2mo ago↗ source
  • Replimune takes third swing at cancer drug approval following ‘productive’ FDA talks
    A twice-spurned therapy that’s been seen as one of the FDA’s more controversial recent rejections is getting a new chance following the resignation of former commissioner Marty Makary.
    BioPharma Dive · 2mo ago↗ source
  • Allogene CEO to step down; Agios drug fails key test
    David Chang will leave his post after an eight-year run at the cell therapy maker. Elsewhere, a next-generation blood disease drug stumbled and an acquisition yielded an FDA approval for AbbVie.
    BioPharma Dive · 2mo ago↗ source
  • Can a chaotic FDA still deliver on faster drug development?
    As leadership changes create more instability at the FDA, here’s what one former agency official thinks it will take to keep speedier drug approvals on track.
    BioPharma Dive · 2mo ago↗ source
  • FDA Issues Draft Guidance to Cut Unnecessary Animal Testing for Cancer Drugs
    The U.S. Food and Drug Administration today issued a draft guidance to reduce unnecessary animal testing in nonclinical safety assessments for certain cancer drugs.
    fda press · 2mo ago↗ source
  • Pfizer, Innovent strike $10B cancer drug deal
    Involving up to 12 antibody drugs, the alliance is the latest broad partnership between Chinese biotech and a multinational pharmaceutical company.
    BioPharma Dive · 2mo ago↗ source
  • GSK, Ionis unveil data for hepatitis B drug touted as ‘functional cure’
    The findings supporting bepirovirsen were deemed a “historic moment” by physicians and validate a drug that has “clear blockbuster potential,” according to one analyst.
    BioPharma Dive · 2mo ago↗ source
  • CVS obesity drug deal puts Lilly on equal footing with Novo
    The agreement includes Lilly’s new pill Foundayo and restores coverage for Zepbound, erasing what had been a commercial edge for rival Novo Nordisk.
    BioPharma Dive · 2mo ago↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 2mo ago↗ source
  • FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
    FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products
    fda press · 2mo ago↗ source
  • BioMarin drug acquired in buyout misses goal in rare disease study
    Tested in a condition known as ENPP1 deficiency, the treatment failed a trial goal that’s important to regulators, spurring doubts about its approval prospects.
    BioPharma Dive · 2mo ago↗ source
  • A migraine drugmaker heads to the public markets through reverse merger
    Mentari Therapeutics, a spinout from the prolific hub-and-spoke biotech Paragon, is developing two medications it hopes can treat migraines that aren’t well controlled by existing drugs.
    BioPharma Dive · 2mo ago↗ source
  • Relay drug shows early promise against rare blood vessel diseases
    While early, the findings suggest the therapy could be superior to Novartis’ Vijoice at treating “vascular anomalies,” a cluster of chronic conditions with few available treatments.
    BioPharma Dive · 2mo ago↗ source
  • FDA approves AstraZeneca’s new kind of hypertension drug
    Baxfendy inhibits a blood-pressure-raising enzyme and, according to AstraZeneca executives, is poised to be a “big product” that should ultimately generate $5 billion or more in annual sales.
    BioPharma Dive · 2mo ago↗ source
  • Merck ADC, licensed from China, hits mark in first big global trial
    The endometrial cancer trial is the first of 17 late-stage studies Merck is running for a therapy that’s important to its ambitions of hitting $70 billion in annual sales next decade.
    BioPharma Dive · 2mo ago↗ source
  • Høeg fired in latest FDA shakeup; 20 people die after taking Amgen drug
    The agency has once again shuffled the leadership for two top drug review offices. Elsewhere, Parabilis partnered with Regeneron and an obesity pill is headed toward an approval in China.
    BioPharma Dive · 2mo ago↗ source