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  • Summit Therapeutics and Akeso report Phase 3 survival benefit for ivonescimab in Chinese biliary tract cancer
    Summit Therapeutics and its Chinese partner Akeso said their bispecific antibody ivonescimab combined with chemotherapy improved overall survival for patients with first-line biliary tract cancer i…
    BioSpace · 2h agoPositive readoutPositive↗ source
  • Jazz's Ziihera receives FDA approval for first-line treatment of HER2-positive gastroesophageal cancer
    The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals' bispecific antibody Ziihera for use as a first‑line therapy in patients with unresectable locally advanced or metastatic gas…
    BioSpace · 4h agoApprovalPositive
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  • Aurora Therapeutics halts lead CRISPR program and cuts staff
    Aurora Therapeutics, founded as the first company dedicated to developing custom CRISPR-based gene-editing medicines, announced a major restructuring. The firm said it is laying off several employ…
    Endpoints · 1h agoLayoffsNegative↗ source
  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 5h agoPositive readoutPositive↗ source
  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 5h agoDealPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 5h agoRegulatoryNeutral↗ source
  • CDMO hiring struggles as demand for specialized talent outpaces supply
    Contract development and manufacturing organizations are finding it harder to fill positions, according to a search expert who tracks life-science talent. The surge in outsourcing has created a gap…
    BioSpace · 9h agoNeutral↗ source
  • Spyre Therapeutics deprioritizes anti-TL1A rheumatoid arthritis candidate after modest Phase 2 results
    Spyre Therapeutics said on Tuesday it will shift resources away from its anti-TL1A antibody that was being developed for rheumatoid arthritis. The decision follows the Phase 2 study, which showed…
    Endpoints · 5h agoNegative readoutNegative↗ source
  • Inside the Gulf biotech deal model, ahead of RGMBS 2026 in Riyadh
    Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14…
    BioSpace · 11h agoDealNeutral↗ source
  • BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026
    BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…
    BioSpace · 4h agoNeutral↗ source
  • FDA reportedly weighing two new deputy commissioner roles, one for health AI and one for drugs
    The Food and Drug Administration is said to be considering the creation of two additional deputy commissioner positions. The proposal is being reported by media outlets but has not been confirmed b…
    BioSpace · 4h agoRegulatoryNeutral↗ source
  • RevMed receives early FDA approval for ‘groundbreaking’ pancreatic cancer drug
    The FDA granted the approval of Revolution Medicines' daraxonrasib, now to be known as Rasonque, in pancreatic adenocarcinoma 6.5 months ahead of deadline.
    BioSpace · 42m ago↗ source
  • Haisco grants license to Sentivera; ViiV's HIV treatment OK'd for newborns
    Haisco Pharmaceutical licenses inflammatory disease drug to Sentivera: The Chinese biotech is granting ex-China rights for the unnamed candidate to US startup Sentivera, which was founded by ARCH V…
    Endpoints · 54m ago↗ source
  • FDA approves Revolution Medicines' pancreatic cancer drug
    The FDA gave the green light to a highly anticipated pancreatic cancer treatment that has altered the prospects for patients facing the deadly disease. The agency on Wednesday approved Revolution M…
    Endpoints · 55m ago↗ source
  • FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
    The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanc…
    fda press · 1h ago↗ source
  • BMS ends Cellares pact over cell therapy production problems, triggering layoffs
    Setbacks to efforts to use Cellares’ automated platform to make an approved CAR-T cell therapy led BMS to terminate its partnership with the manufacturing specialist.
    BioSpace · 3h ago↗ source
  • Biohaven could get up to $795M in epilepsy alliance with SK Bio
    At the center of Biohaven’s agreement with SK Biopharmaceutical is the ion channel platform and the lead epilepsy candidate opakalim, for which Phase 2/3 data are expected later this year.
    BioSpace · 3h ago↗ source
  • FDA greenlights Revolution Medicines' pancreatic cancer gamechanger
    Following dynamite data that earned a standing ovation at the American Society of Clinical Oncology in May, Revolution Medicines’ Ras inhibitor daraxonrasib has been approved by the FDA for the tre…
    Fierce Biotech · 4h ago↗ source
  • Hansoh heralds China’s move from ‘follower’ to ‘frontrunner’ in biopharma race
    Hansoh Pharmaceutical has given a bullish assessment of China’s innovative pharma sector, arguing that the industry is “fully transitioning from the ‘follower’ to the ‘frontrunner’ phase.”
    Fierce Biotech · 6h ago↗ source
  • JATT mastermind launches latest biotech-focused SPAC via $60M IPO
    Just two months after Someit Sidhu, M.D., succeeded in pairing off his second special purpose acquisition company (SPAC) with Talawar Therapeutics, the biotech entrepreneur is back at it again.
    Fierce Biotech · 6h ago↗ source
  • Boston Scientific hit by cyberattack causing ‘disruptions’ to parts of its business
    This year has seen a growing number of medtechs hit by cyberattacks, and now Boston Scientific has become the latest victim.
    Fierce Biotech · 8h ago↗ source
  • Spyre’s rheumatoid arthritis plan toppled by subpar TL1A data
    Phase 2 data on Spyre Therapeutics’ anti-TL1A antibody SPY072 in rheumatoid arthritis have fallen short of expectations, prompting the biotech to deprioritize monotherapy development in the indicat…
    Fierce Biotech · 10h ago↗ source
  • SK Biopharma pens $795M deal to usher Biohaven’s epilepsy therapy towards hoped-for 2029 launch
    SK Biopharmaceuticals has strengthened its epilepsy offering by paying $350 million upfront to help speed Biohaven’s Kv7 ion channel activator on its way to market.
    Fierce Biotech · 11h ago↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 21h agoApprovalPositive↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 1d agoApprovalPositive↗ source