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21 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 · 2d agoLayoffsNegative↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 6d agoNegative readoutNegative↗ source
28
fda recalls22
fda press21
fda medwatch17
395
Psychiatry & CNS340
Ophthalmology169
Infectious Disease165
Pain160
Nephrology159
  • 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
  • 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 · 16d ago↗ source
  • FDA rejects Hengrui-Elevar liver cancer drug combo for third time
    For the third time in about two years, the FDA has cited manufacturing deficiencies in rejecting a drug combination from Jiangsu Hengrui Pharmaceuticals and Elevar Therapeutics intended to treat th…
    Endpoints · 20d 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 · 23d 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
  • City Therapeutics gets $99M to gather data on three RNAi medicines
    City Therapeutics, the next-gen RNAi startup founded and led by former Alnylam executives, has collected $99.5 million to fund the clinical development of its first three candidates and expand into…
    Endpoints · 1mo ago↗ source
  • GSK inks multi-target pact with Engitix; Sangamo considers strategic options
    Plus news about Pfizer's latest label expansion. 🤝 GSK inks multi-target liver pact with Engitix: London-based Engitix will use disease models based on its extracellular matrix technology to ident…
    Endpoints · 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
  • #ASCO26: AstraZeneca's triplet combo succeeds in liver cancer subgroup
    CHICAGO — AstraZeneca on Monday reported data from a new study showing the combination of a targeted treatment and two immunotherapies can benefit patients with certain kinds of liver cancer. Indiv…
    Endpoints · 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
  • Amgen stands by rare disease drug Tavneos amid Japan liver toxicity report
    The FDA wants it off the market. European regulators are investigating data-integrity concerns. And now, a pharma company selling the drug in Japan is warning doctors against writing new prescripti…
    Endpoints · 2mo 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