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  • GSK receives FDA approval for ROS1 inhibitor Jideytro, marking its first lung cancer drug
    GSK's FDA approval of Jideytro, a ROS1 inhibitor for advanced non-small cell lung cancer patients with ROS1 gene fusions who have already received ROS1-directed therapy, was announced on Wednesday.…
    BioSpace · 28d agoApprovalPositive↗ source
  • Lilly's obesity drug shows strong weight loss but fails to demonstrate cardiovascular benefit in heart disease trial
    Eli Lilly released Phase 3 results for its next‑generation obesity therapy retatrutide, showing it produces substantial weight loss in a trial of nearly 2,000 participants with severe obesity and e…
    STAT · 27d agoNegative readoutNeutral↗ source
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  • Eli Lilly's retatrutide shows strong weight loss but no clear heart risk reduction in Phase 3 trial
    Eli Lilly released new data from a Phase 3 trial of retatrutide, its next‑generation obesity drug. The study enrolled nearly 2,000 participants with severe obesity and existing heart disease, some…
    STAT · 28d agoNegative readoutNegative↗ source
  • Scancell to list on Nasdaq after reverse merger with Neuphoria, funds $89M for melanoma immunotherapy trial
    Scancell announced that it will become a publicly traded company on Nasdaq after completing an all‑stock reverse merger with Neophobia Therapeutics. The transaction gives Scancell a new ticker, SCL…
    Fierce Biotech · 28d agoDealPositive↗ source
  • EMA moves quickly to enforce clinical trial result reporting across Europe
    The European Medicines Agency announced new measures aimed at ensuring that results of clinical trials are posted publicly in line with legal obligations. The steps follow an analysis that found f…
    STAT · 27d agoRegulatoryPositive↗ source
  • Sanofi's Lantus Solostar insulin pen faces supply challenges, patients struggle to find product
    Sanofi's Lantus Solostar pen, a long-acting insulin glargine product, has become hard to locate in pharmacies. The company says demand has risen due to broader market dynamics, and while the FDA h…
    STAT · 27d agoNegative↗ source
  • Congress rushes health-care bills on price transparency and prior authorization before August recess
    Congress is trying to pass a bundle of health-care legislation in the final week before the House and Senate adjourn for the August recess. Lawmakers are focusing on measures that would increase p…
    STAT · 27d agoRegulatoryNeutral↗ source
  • FDA advisory panel to decide on compounding of synthetic peptides amid safety concerns
    The FDA advisory committee is meeting to consider whether compounding pharmacies should be allowed to manufacture seven specific synthetic peptides. Use of these peptides has grown in the United St…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Biotech hubs from Abu Dhabi to Brazil compete to become the next emerging economy
    Fierce reporters attended the Biotechnology Innovation Organization conference in San Diego to gauge how biotech hubs worldwide are positioning themselves amid tariff concerns and China’s growing i…
    Fierce Biotech · 27d agoNeutral↗ source
  • BeOne invests $300 million in New Jersey plant, adding small-molecule capacity and 120 jobs
    BeOne Medicines announced a $300 million investment to expand its manufacturing campus in Hopewell, New Jersey. The expansion will include a three‑story, 145,000‑square‑foot building for small‑mol…
    BioSpace · 27d agoDealPositive↗ source
  • Senate health committee delays vote on Trump nominee for ASPR amid anti-vaccine controversy
    The Senate health committee postponed its vote on Sean Kaufman, the Trump administration’s pick to lead the Office of the Assistant Secretary for Preparedness and Response (ASPR). The delay came ju…
    STAT · 27d agoRegulatoryNegative↗ source
  • HHS, FDA and partners to convene experts on clinical AI standards
    The White House, the Department of Health and Human Services, the FDA and the Office of the National Coordinator for Health Information Technology are bringing together experts to discuss how clini…
    STAT · 27d agoRegulatoryNeutral↗ source
  • Roche says its late-stage pipeline is full, sees growth through 2030
    Roche's CEO Thomas Schinecker told analysts that the company has 19 investigational medicines that could launch by 2030, indicating a robust late-stage pipeline. He added that the depth of the pip…
    BioSpace · 28d agoEarningsPositive↗ source
  • FDA peptide panel faces clash as Ebola outbreak kills over 1,000 and vaccine options remain limited
    The FDA is holding a two‑day panel on peptide therapeutics, and observers anticipate heated debate among regulators and industry. The African CDC reports the fastest‑growing Ebola outbreak, with m…
    STAT · 28d agoRegulatoryNeutral↗ source
  • Biopharma firms must prioritize hiring and retaining commercial talent for successful drug launches
    A BioSpace webinar brought together commercial leaders and a recruiting specialist to discuss how biopharma companies can better hire and keep commercial staff as they prepare for new product launc…
    BioSpace · 28d agoNeutral↗ source
  • Biopharma layoffs must double in second half of 2026 to match 2025 cuts
    The first half of 2026 saw biopharma companies cut slightly fewer jobs than the same period a year earlier, with layoffs affecting about 2% fewer employees overall. To reach the total workforce re…
    BioSpace · 28d agoLayoffsNegative↗ source
  • Roche halts lupus T-cell engager RG6382 development after early trial review
    Roche announced it is stopping work on RG6382, a bispecific T-cell engager targeting CD19 and CD3, which was being tested in a phase‑1 study in patients with systemic lupus erythematosus (SLE). Th…
    Fierce Biotech · 28d agoNegative↗ source
  • FDA approves Johnson & Johnson's Ottava robotic system for multiple soft-tissue surgeries
    FDA cleared Johnson & Johnson's Ottava robotic surgical system, marking its entry into the market. The clearance covers a range of soft-tissue procedures such as gastric bypass, gastrectomy, chole…
    Fierce Biotech · 28d agoApprovalPositive↗ source
  • Advocacy group Public Citizen petitions FDA to ban direct-to-consumer prescription drug ads
    Public Citizen has filed a petition with the U.S. Food and Drug Administration calling for a ban on direct-to-consumer advertising of prescription medicines. The group argues that such ads are des…
    STAT · 27d agoRegulatoryNegative↗ source
  • FDA advisory panel to debate allowing compounding pharmacies to produce unapproved peptides
    FDA advisers will convene on Thursday and Friday to discuss a proposal that would let compounding pharmacies manufacture seven synthetic peptides that are currently classified as unsafe for compoun…
    STAT · 28d agoRegulatoryNegative↗ source
  • Roche Diagnostics sales rise only 3% in H1 2026 as China pricing reforms weigh
    Roche Diagnostics reported sales of 6.73 billion Swiss francs for the first half of 2026, a 3% increase at constant exchange rates but a 3% decline in reported franc terms. Growth was limited by p…
    Fierce Biotech · 28d agoEarningsNegative↗ source
  • Clinuvel to relocate HQ to US and cut up to 20% of staff
    Clinuvel Pharmaceuticals, an Australian biotech, announced it will move its corporate headquarters to the United States starting Jan 1, 2027. The company said the shift is aimed at attracting U.S.…
    Fierce Biotech · 28d agoLayoffsNegative↗ source
  • FDA says it has not paused CRL releases amid transparency push
    An unnamed pharmaceutical company filed a citizen petition in April asking the FDA to change how it publicly releases Complete Response Letters, arguing the new policy conflicts with long‑standing…
    BioSpace · 27d agoRegulatoryNeutral↗ source
  • Formation Bio appoints veteran biotech leader Michael Ehlers as chief scientific officer
    Formation Bio, an AI-focused biotech, announced the hiring of Michael Ehlers, M.D., Ph.D., as its chief scientific officer and head of research and development. Ehlers brings a blend of academic a…
    Fierce Biotech · 27d agoPositive↗ source
  • Podcast explores father's quest for ultra‑rare disease therapy, telehealth GLP‑1 prescribing probe and fugitive posing as biotech exec
    The latest episode of STAT’s "The Readout Loud" podcast examines three distinct stories that intersect with the biotech world. Hosts Allison DeAngelis and Elaine Chen sit down with colleagues Jason…
    STAT · 27d agoNeutral↗ source