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19 stories matching this filter · ← front page

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  • 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 · 3d agoEarningsPositive↗ source
  • 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 · 9d ago↗ source
28
fda recalls23
fda press21
fda medwatch18
571
Vaccines517
Endocrinology & Metabolism293
Ophthalmology258
Infectious Disease253
Nephrology239
Arbutus, Sanofi escalate mRNA patent fights; InnoCare’s TYK2 contender advances
The new lawsuits add to a web of legal disputes over technology involved in COVID vaccines. Elsewhere, a prolific AI biotech inked another deal and Insmed strengthened support for a closely watched…
BioPharma Dive · 15d ago↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 21d ago↗ source
  • Beyond Boston: Unlikely cities stake biotech claims
    As Greater Boston’s biotech industry sheds jobs, three unlikely regions are showing promise as up-and-coming hubs.
    BioPharma Dive · 26d ago↗ source
  • Top FDA gene and cell therapy regulator to step down
    Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Moderna flu vaccine wins unanimous support from FDA panel
    The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
    BioPharma Dive · 1mo ago↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 1mo ago↗ source
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 1mo ago↗ source
  • FDA staff scrutinizes evidence supporting Moderna’s flu vaccine
    Ahead of a Thursday advisory panel meeting, agency scientists highlighted shortcomings in data accrued for a vaccine the FDA controversially refused to even review earlier this year.
    BioPharma Dive · 1mo 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
  • 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
  • FDA’s leadership void leaves biotech with renewed ‘uncertainty’
    Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted policies with an unclear future.
    BioPharma Dive · 2mo ago↗ source
  • FDA chief Marty Makary resigns from agency, ending tumultuous tenure
    Makary’s exit ends a turbulent run marred by leadership upheaval, mass layoffs, political pressure and public spats with drugmakers.
    BioPharma Dive · 2mo ago↗ source
  • Dr Parikh on the Feasibility and Importance of Immunotherapy Trials in Anal Cancer
    Aparna R. Parikh, MD, discusses how trials like PODIUM-303 are reshaping the treatment paradigm for squamous cell anal carcinomas.
    onclive · 2mo ago↗ source
  • Dr Sznol on the Nuances of Recommending Neoadjuvant Therapy in Metastatic Melanoma
    Mario Sznol, MD, discusses current guidance around the use of neoadjuvant therapy in advanced melanoma.
    onclive · 2mo ago↗ source
  • Moderna sees revenue bump from international COVID vaccine sales
    The company is making up for a decline in U.S. vaccine sales with better results elsewhere, continuing a turnaround that’s vaulted its stock price in 2026.
    BioPharma Dive · 3mo ago↗ source
  • Moderna, after losing US funding, rebounds to start mRNA bird flu vaccine trial
    A program that got caught up in HHS’ decision to abandon mRNA research was revived by a public-private coalition and is now beginning a large, late-stage test that could support a future approval.
    BioPharma Dive · 3mo ago↗ source