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1,444 stories matching this filter · ← front page

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  • FDA’s push to publish complete response letters faces legal uncertainty and possible pause
    The FDA began releasing complete response letters (CRLs) to the public last year, a move promoted as increasing transparency for drug developers, investors, and patients. However, the policy has e…
    BioSpace · 26d agoRegulatoryNegative↗ source
  • UK biotech venture capital funding hits record high in Q2 2026, surpassing any full year since 2022
    UK biotech companies secured more venture capital in the second quarter of 2026 than they did in any full calendar year since 2022. The surge reflects a broader fundraising revival, with investors…
    Endpoints · 26d agoDealPositive↗ source
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  • Bristol Myers Squibb partners with Nvidia to build pharma's most advanced AI supercomputer
    Bristol Myers Squibb announced it will construct what it calls the most advanced and energy-efficient AI supercomputer system in the biopharma sector. The project will be carried out in partnershi…
    Endpoints · 26d agoDealPositive↗ source
  • Kyverna Therapeutics aims to file first CAR-T cell therapy for autoimmune disease
    Kyverna Therapeutics is preparing what could become the first regulatory filing for a CAR-T cell therapy targeting an autoimmune condition. The company has been developing its miv-cel construct in…
    BioSpace · 26d agoRegulatoryPositive↗ source
  • UnitedHealth outlines AI rollout as quarterly results beat expectations
    UnitedHealth Group, a major health insurer, announced a substantial investment in artificial intelligence earlier this year. The company recently detailed how the technology is being integrated in…
    Endpoints · 26d agoPositive↗ source
  • House lawmakers support US trade panel's probe into China's biotech sector and pricing practices
    At least ten members of the U.S. House of Representatives have voiced support for a trade investigation targeting China’s biotechnology industry. The investigation, led by a U.S. trade panel, will…
    Endpoints · 26d agoRegulatoryNeutral↗ source
  • J&J and AbbVie also considered AtaiBeckley before Lilly’s $2.8 B acquisition
    Johnson & Johnson and AbbVie were reported to have evaluated AtaiBeckley as a potential target in the psychedelic market. The companies did not submit an offer before Eli Lilly closed its $2.8 bil…
    Endpoints · 26d agoDealNeutral↗ source
  • Bristol Myers teams with Nvidia to launch large AI data center as Samsung Biologics bids $1.8 bn for Swiss peptide maker
    Bristol Myers Squibb announced expansion of its partnership with Nvidia, deploying two AI systems to create a powerful AI factory for life‑science research, aiming to tackle larger problems without…
    BioPharma Dive · 26d agoDealNeutral↗ source
  • Scribe targets $96 million from Nasdaq IPO as Scholar Rock awaits site classification for apitegromab
    Scribe, a gene-editing biotech, announced plans for a Nasdaq initial public offering that could raise roughly $96 million. The company said it would price the shares at $14 each, which is the midp…
    Endpoints · 26d agoDealNeutral↗ source
  • Biogen reports mixed Alzheimer’s trial results as industry sees new startup launches
    Biogen released data from its Alzheimer’s program that showed mixed outcomes, indicating some signals but also setbacks. The weekly newsletter also highlighted the launch of two new biotech startu…
    Endpoints · 28d agoNeutral↗ source
  • Compounders still supply about 20% of US GLP-1 weight-loss market despite FDA crackdown and shortages
    A recent Gallup survey shows that while the number of Americans taking GLP-1 weight‑loss drugs has nearly quadrupled over the past two years, roughly one in five are using cheaper, non‑FDA‑approved…
    BioPharma Dive · 29d agoRegulatoryNegative↗ source
  • BlossomHill and Latigo lead a surge of biotech IPOs after summer dry spell
    After a seven‑month lull that left no biotech companies on the public markets last summer, the sector is seeing renewed activity. BlossomHill Therapeutics and Latigo have filed to list on Nasdaq,…
    Endpoints · 29d agoDealPositive↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 29d agoNegative readoutNegative↗ source
  • Mid-size biotech firms urge White House to scrap CMS GLOBE and GUARD pricing proposals
    A group of midsized biotechnology companies met with officials from the White House and the Department of Health and Human Services this week. The companies presented a coordinated case to senior p…
    Endpoints · 29d agoRegulatoryNegative↗ source
  • Celcuity's Revtorpyk receives FDA approval, but launch delay pushes stock lower
    The FDA announced approval of Celcuity’s oncology candidate Revtorpyk on Tuesday, marking the company’s first cancer drug clearance. Analysts had broadly expected the approval and had priced the s…
    Endpoints · 29d agoApprovalNeutral↗ source
  • Jasper Therapeutics secures $132 million and merges with Kira Pharmaceuticals to revive pipeline
    Jasper Therapeutics, a cash‑strapped biotech, announced it completed an all‑stock acquisition of privately held immune‑drug developer Kira Pharmaceuticals. The merger is paired with a private stoc…
    BioPharma Dive · 29d agoDealPositive↗ source
  • India’s life-sciences sector faces scaling hurdles despite rapid innovation growth, report says
    India’s life‑sciences sector has shown rapid growth, according to a new report by Boston Consulting Group and HealthKois. Patent filings have risen more than four‑fold since 2016, the pipeline of i…
    BioSpace · 29d agoNeutral↗ source
  • GSK to launch large trial testing shingles vaccine’s potential to reduce Alzheimer’s risk
    GSK announced it will conduct a large-scale clinical study to evaluate whether the shingles vaccine can lower the risk of developing Alzheimer’s disease. The move follows observations from analyses…
    Endpoints · 29d agoNeutral↗ source
  • Arbutus and Sanofi launch new patent lawsuits against Pfizer, BioNTech and Moderna over mRNA lipid nanoparticle technology
    Arbutus BioPharma filed three new lawsuits against Pfizer and BioNTech, accusing them of infringing patents covering the lipid nanoparticle (LNP) technology used to deliver mRNA vaccines. The filin…
    BioPharma Dive · 29d agoRegulatoryNegative↗ source
  • AI-discovered drugs show early promise but face mixed results in clinical trials
    AI is being promoted as a way to cut the cost and time of drug research and development, which can exceed $2.6 billion and take up to 15 years. Only a handful of AI‑identified compounds have enter…
    BioPharma Dive · 29d agoNeutral↗ source
  • GSK drops chronic cough drug camlipixant after mixed Phase 3 results
    GSK announced it will stop investing in camlipixant for refractory chronic cough after the drug failed to meet key endpoints in a late-stage trial. The company had run two Phase 3 studies, CALM-1…
    BioSpace · 29d agoNegative readoutNegative↗ source
  • Insmed's inhaled PAH therapy shows durable efficacy in 12-month extension, bolstering $6B sales outlook
    Insmed reported that its inhalable prostanoid candidate, treprostinil palmitil inhalation powder (TPIP), maintained functional and biomarker benefits through a 12‑month open‑label extension in pati…
    BioSpace · 29d agoPositive readoutPositive↗ source
  • FDA says former officials' journal articles do not represent agency policy after lawmaker criticism
    Acting FDA director Kyle Diamantas wrote to House Energy & Commerce ranking member Diana DeGette, stating that journal papers authored by former agency officials do not convey FDA policy or regulat…
    BioSpace · 29d agoRegulatoryNegative↗ source
  • GSK halts Phase 3 chronic cough drug camlipixant, jeopardizing $2 billion Bellus Health acquisition
    GSK announced it is ending development of camlipixant, a drug aimed at treating refractory chronic cough, after completing Phase 3 trials. The move comes as the company proceeds with its planned $…
    Endpoints · 29d agoNegative↗ source
  • Dimerix acquires Mission’s acute kidney injury candidate for $5 million upfront
    Dimerix announced it has signed a deal to acquire a kidney injury drug candidate from Mission Therapeutics. The asset is ready to enter Phase 2 trials for the treatment of acute kidney injury. Und…
    Endpoints · 29d agoDealPositive↗ source