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22 stories matching this filter · ← front page

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  • GSK prepares for patent cliff with $2.5B cost-cutting plan
    The pharma hasn’t yet revealed what kind of job cuts might be involved in the plan, which will help it absorb the coming loss of patents important to its HIV drug franchise.
    BioPharma Dive · 3d agoLayoffsNegative↗ 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 · 9d ago↗ source
28
fda recalls22
fda press21
fda medwatch18
Vaccines516
Endocrinology & Metabolism290
Ophthalmology255
Infectious Disease253
Nephrology239
Fresh off buyout, Akero execs reunite to advance long-acting psoriasis pill
Set to go public via a reverse merger, Avere has licensed from a prolific Chinese drugmaker rights to a potential threat to medicines like Skyrizi and Icotyde.
BioPharma Dive · 17d ago↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 24d ago↗ source
  • These biotechs just landed big fundraising hauls. Here’s what they pitched to investors.
    Biotechs aimed at eye diseases, autoimmune conditions and longevity medicine have pulled in some of the largest capital raises so far this year.
    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
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 1mo ago↗ source
  • City banks nearly $100M for next-gen RNAi drugs
    Co-founded by longtime Alnylam CEO John Maraganore, City has brought a clotting disorder drug into early human testing. An experimental therapy for Stargardt disease could soon follow.
    BioPharma Dive · 1mo ago↗ source
  • Pharma is betting big on PD-1/VEGF bispecifics. But are companies chasing the wrong target?
    While many drugmakers are focused on lung cancer, evidence shows the liver may be a better bet.
    BioPharma Dive · 1mo ago↗ source
  • NewLimit’s $435M megaround; Lilly’s busy dealmaking week
    The anti-aging biotech has secured one of the year’s biggest venture fundings to bring its first drug into testing. Elsewhere, Lilly nabbed a “GLP-2” obesity drug and Praxis shares tumbled.
    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
  • 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
  • With new data, Regenxbio to seek FDA approval of Duchenne gene therapy
    Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”
    BioPharma Dive · 2mo ago↗ source
  • GSK cuts deal with Sino to broaden reach of hepatitis B drug
    The marketing deal is the latest in a series of recent pacts between GSK and China-based drug companies, and could speed access to a therapy called bepirovirsen that’s important to its future.
    BioPharma Dive · 2mo ago↗ source
  • Avalo shares spike on skin drug data; BioNTech to cut staff
    Avalo reported study success in what’s proven to be a tough-to-treat skin disease. Elsewhere, BioNTech announced plans to close multiple plants and Madrigal picked up an RNA-based drug for MASH.
    BioPharma Dive · 2mo ago↗ source
  • Two biotechs raise a combined $556M in latest spurt of IPOs
    Seaport Therapeutics and Hemab Therapeutics on Thursday became the latest drugmakers to debut on Wall Street, continuing a stretch of large IPOs this year that collectively raised almost $3.2 billion.
    BioPharma Dive · 3mo ago↗ source
  • FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech
    Through two pioneering studies, Amgen and AstraZeneca will share study data with FDA scientists as it’s accrued. Elsewhere, Lilly inked a gene editing deal and Pfizer reported success for a multipl…
    BioPharma Dive · 3mo ago↗ source
  • Boehringer dual-acting obesity shot hits mark in Phase 3 trial
    Survodutide spurred weight loss Wall Street analysts referred to as “Wegovy-like,” and showed signs it might help preserve muscle mass as well.
    BioPharma Dive · 3mo ago↗ source
  • Intellia CRISPR drug succeeds in late-stage study against rare swelling disorder
    The findings position Intellia to bring to market the first “in vivo” gene editing medicine, though the therapy’s commercial potential remains the source of intense investor debate.
    BioPharma Dive · 3mo ago↗ source
  • Sanofi MS drug rejected in US gets an endorsement in Europe
    Tolebrutinib, which the FDA recently turned back due to safety concerns, received a positive recommendation that positions the therapy for its first regulatory approval.
    BioPharma Dive · 3mo ago↗ source
  • Sanofi posts upbeat sales as R&D pressure builds
    A string of research setbacks have left the pharmaceutical giant at a crossroads just as a new CEO is set to take over. But positive first-quarter earnings provided the company with a needed boost.
    BioPharma Dive · 3mo ago↗ source
  • Merck adds to pharma’s AI push; Roche details MS drug results
    Merck is making a $1 billion investment in a deal with Google Cloud. Elsewhere, Roche pitched its case for a closely watched multiple sclerosis pill and Arcus and Gilead are ending a yearslong alli…
    BioPharma Dive · 3mo ago↗ source