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294 stories matching this filter · ← front page

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  • 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
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fda recalls22
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Pain106
Ophthalmology103
Endocrinology & Metabolism94
Nephrology71
↗ 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
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 2mo ago↗ source
  • Unlocking more value from mature drug products through strategic outsourcing
    See how strategic outsourcing can maximize value and reduce costs for mature drug portfolios.
    BioPharma Dive · 2mo ago↗ source
  • FDA hold puts Aardvark Prader-Willi drug in limbo
    The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.
    BioPharma Dive · 2mo ago↗ source
  • Supreme Court preserves access to abortion pill by mail
    The ruling maintains access to the drug while litigation continues. Mifepristone can still be prescribed at pharmacies or by mail without requiring in-person visits.
    BioPharma Dive · 2mo ago↗ source
  • Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers
    Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its latest restructuring and Alumis is discarding a once-highly touted i…
    BioPharma Dive · 2mo ago↗ source