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  • Over 15,000 Science/R&D jobs and 10,800 Clinical roles posted on BioSpace in first eight months of 2026
    BioSpace data shows seven biopharma disciplines each had at least 5,000 live postings during the first eight months of 2026. Science/R&D leads with 15,361 positions, ranging from manager roles at…
    BioSpace · 1mo agoNeutral↗ source
  • FDA officials stress administration priorities in draft PDUFA VIII commitment letter
    At a public meeting on Wednesday, FDA officials presented the proposed commitment letter for the upcoming PDUFA VIII program. The letter reiterates the administration's priorities, reflecting the…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • Novartis drops $125M for Sironax’s tech to cross blood-brain barrier
    Novartis stands alongside Big Pharma peers that have similarly invested in technologies to penetrate the blood-brain barrier, including GSK, Roche and Eli Lilly.
    BioSpace · 1mo ago↗ source
  • Psychedelic therapeutics near first FDA approval as Compass Pathways and Definium report promising results
    BioSpace notes that the psychedelic drug sector is regaining momentum after a setback in 2024 when Lykos’ MDMA therapy failed to win FDA clearance. The focus has shifted to new candidates, with Com…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • FDA holds psychedelic forum as Definium reports third successful Phase 3 trial of oral LSD for anxiety
    The FDA convened a public forum on Monday to discuss the near‑term outlook for psychedelic drug development, highlighting interest from companies such as Compass Pathways and Definium Therapeutics.…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • FDA issues warning letter to Bausch & Lomb over aseptic processing concerns
    FDA sent a warning letter to Bausch & Lomb after inspectors reviewed the company’s response to earlier observations at its Florida plant. The agency said the response did not demonstrate a commitme…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Sling Therapeutics raises $123M Series C to advance oral thyroid eye disease drug
    Sling Therapeutics raised $123 million in a Series C financing round to move its oral drug candidate for thyroid eye disease forward. The capital will fund development of linsitinib, the only late…
    BioSpace · 1mo agoDealPositive↗ source
  • Biotech firms race to hire AI-savvy scientists as talent gap widens
    AI is becoming integral to biotech research and development, prompting companies to seek staff who can blend biology with machine learning and data engineering. Recruiters say the hardest-to-find…
    BioSpace · 1mo agoNeutral↗ source
  • Biotech firms increase product launches as capital markets improve
    A growing number of biotech companies are bringing new medicines to market, a trend analysts link to improving capital markets. While the majority of approved drugs still come from large pharmaceu…
    BioSpace · 1mo agoPositive↗ source
  • Experts urge more representative enrollment in clinical trials
    A panel of regulators and industry leaders gathered to discuss how clinical trials can better reflect the diversity of patient populations. The discussion included officials from the U.S. Food and…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Novartis stops ALS TREM2 stabilizer after Phase 2 miss, marking fourth trial setback in a month
    Novartis has halted development of its TREM2 stabilizer VHB937, also known as lifonebart, for amyotrophic lateral sclerosis after the drug failed to meet either the primary or secondary endpoints i…
    BioSpace · 1mo agoNegative readoutNegative↗ source
  • Experts assess EU medical device and diagnostic regulations at RAPS Convergence 2026
    A panel of experts representing the European Commission, industry groups and notified bodies gathered in Charlotte, North Carolina during RAPS Convergence 2026. The group reviewed the current stat…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Biopharma workers increasingly postpone retirement, poll shows 52% plan to stay longer
    Biopharma professionals are rethinking retirement, with a BioSpace LinkedIn poll indicating that 52% expect to retire later than originally planned. Overall, 63% of respondents said they have chang…
    BioSpace · 1mo agoNeutral↗ source
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source
  • GSK to acquire Chimagen’s trispecific T-cell engager program in deal up to $750 million
    GSK announced it will acquire a preclinical trispecific T cell engager program from Chinese biotech Chimagen Biosciences in a transaction that could total up to $750 million. The agreement provide…
    BioSpace · 1mo agoDealPositive↗ source
  • Medtronic and Given Imaging recall Bravo CF esophageal pH monitoring capsule delivery devices
    Medtronic and its subsidiary Given Imaging have issued a recall of the Bravo CF esophageal pH monitoring capsule delivery devices after reports that the capsules may fail to attach or detach from t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA launches Operation TrialBlazer to accelerate early-stage drug trials and bring research back to the U.S.
    The FDA announced it is now accepting applications for Operation TrialBlazer, an expedited IND pilot program. The program pairs drug sponsors with qualified U.S. research institutions to cut the r…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Stakeholders call on FDA to set safety and treatment standards for emerging psychedelic therapies
    At a recent public hearing, experts and other stakeholders emphasized the need for clear safety and access guidelines as psychedelic medicines move closer to market. The FDA is intensifying effort…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Cullinan-Taiho eye FDA filing for zipalertinib after trial shows strong PFS benefit despite three deaths
    Cullinan Therapeutics and its partner Taiho Oncology said they will seek FDA approval for zipalertinib, an oral therapy for a subset of non‑small cell lung cancer, based on data from a late‑stage s…
    BioSpace · 1mo agoPositive readoutNeutral↗ source
  • Blood centers poised to boost cell and gene therapy supply chains
    Blood centers have the donors, resources and community footprint that drug sponsors need to address supply chain bottlenecks for cell and gene therapies. Cell and gene therapies such as CAR‑T and…
    BioSpace · 1mo agoPositive↗ source
  • FDA launches pilot program to speed early-phase drug trials
    The U.S. Food and Drug Administration announced a new pilot program aimed at accelerating the review of Phase 1 clinical trials for investigational new drugs. The initiative introduces a rolling s…
    raps · 1mo agoRegulatoryPositive↗ source
  • Experts urge FDA to establish safety and access guidelines for psychedelic drugs; GSK to close German vaccine plant
    Experts are urging the U.S. Food and Drug Administration to set clear safety and access standards for psychedelic medicines, according to the briefing. The request reflects growing interest in the…
    raps · 1mo agoRegulatoryNeutral↗ source
  • GSK to cut 650 jobs as it shuts German vaccine plant and consolidates production in Canada
    GSK announced it will close its vaccine manufacturing facility in Dresden, Germany, resulting in about 650 layoffs. The decision follows a review and aligns with a $2.5 billion cost‑saving program…
    BioSpace · 1mo agoLayoffsNegative↗ source
  • FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapses
    The U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
    raps · 1mo agoRegulatoryNegative↗ source
  • Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting
    The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal…
    BioSpace · 1mo agoRegulatoryNeutral↗ source