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  • FDA expands Jazz's Ziihera to frontline HER2-positive gastroesophageal cancers, unlocking $1.5 billion market
    The U.S. Food and Drug Administration has broadened the approved use of Jazz Pharmaceuticals' cancer therapy Ziihera. The drug can now be given as an initial treatment for patients with HER2‑positi…
    BioPharma Dive · 1h agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 11h agoRegulatoryPositive↗ source
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  • FDA clears Roche and Eli Lilly's blood test for early Alzheimer’s detection
    The U.S. FDA has granted clearance for a new blood test developed by Roche and Eli Lilly that measures phosphorylated tau 217 (pTau217) to help rule in or rule out Alzheimer’s disease. The Elecsys…
    BioPharma Dive · 5h agoApprovalPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 8h agoDealPositive↗ source
  • Venture funding for women’s health startups drops sharply after 2024 peak, AI may drive rebound
    Venture capital flowing into women’s health companies fell sharply after reaching record levels in 2024. A Silicon Valley Bank report shows total funding dropped from about $3.2 billion in 2024 to…
    BioPharma Dive · 10h agoNeutral↗ source
  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 18h agoRegulatoryNeutral↗ source
  • Bausch + Lomb moves dry-eye eye drop to Phase 3 despite missing primary endpoint in Phase 2
    Bausch + Lomb reported results of a Phase 2 trial of its dual-action dry-eye eye drop, which combines 5% lifitegrast (the active ingredient in Xiidra) with perfluorohexyloctane (PHFO, sold as Miebo…
    BioSpace · 10h agoNegative readoutNeutral↗ source
  • Massachusetts biopharma employment slips 3.1% in 2025 as R&D jobs fall, while manufacturing rises
    A new MassBio industry snapshot shows that total biopharma employment in Massachusetts fell 3.1% in 2025, translating to roughly 3,600 fewer jobs compared with the previous year. The decline was m…
    BioSpace · 15h agoNeutral↗ source
  • Massachusetts biotech startups see funding gap widen as seed rounds shrink and Series A deals surge
    A MassBio report shows that mature biotech firms in Massachusetts captured most of the venture capital in the first half of 2026, with nearly $3.5 billion invested, a 25% rise from the same period…
    BioPharma Dive · 18h agoNeutral↗ source
  • Baxter Recalls One Lot of 70% Dextrose Injection Over Stainless Steel Particulate Risk
    Baxter International announced a voluntary recall of a single lot of its 70% Dextrose Injection after detecting potential stainless steel particles in the solution. The presence of these particles…
    fda medwatch · 18h agoCRLNegative↗ source
  • Biotech IPOs approach ‘escape velocity’ barring yellow flags that could threaten rebound
    Twenty-five biotechs have used the IPO route to go public this year—with five of those debuts occurring this month alone. It’s the most IPOs since 2021, when the industry recorded 78 during the hei…
    BioSpace · 8h agoRegulatoryNeutral↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 8h agoLayoffsNegative↗ source
  • Better Bakehouse recalls Donutful chocolate‑dipped vanilla cake donuts over undeclared milk allergen
    The Better Bakehouse Snack Company announced a recall of certain lots of its Donutful Chocolate Dipped Vanilla Cake Donuts because the product may contain undeclared milk, creating a serious risk f…
    fda recalls · 21h agoCRLNegative↗ source
  • FDA places second clinical hold on Regenxbio’s Hunter syndrome gene therapy after spinal masses detected
    The FDA issued another clinical hold on Regenxbio’s RGX-121 gene therapy for Hunter syndrome after investigators found spinal masses in five trial participants. The masses, observed on MRI scans,…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • Roche's Genentech signs up to $2.3B deal with Hanmi for weight-loss drug that preserves lean mass
    Roche, through its Genentech subsidiary, has entered a licensing agreement with South Korea's Hanmi Pharm that could be worth up to $2.3 billion, including a $190 million upfront payment. The deal…
    BioSpace · 1d agoDealPositive↗ source
  • FDA pushes back decision on Capricor’s Duchenne cell therapy, GSK clears hepatitis B drug in Japan
    The U.S. Food and Drug Administration has extended its review of Capricor Therapeutics' experimental Duchenne muscular dystrophy cell therapy, deramiocel. The agency moved its decision deadline fro…
    BioPharma Dive · 1d agoRegulatoryNeutral↗ source
  • Roche to acquire Hanmi's lean-mass preserving obesity shot in $2.3 bn deal
    Roche announced a partnership with South Korean company Hanmi Pharm to obtain rights to a novel obesity drug outside South Korea. Under the agreement, Roche will pay $190 million upfront and could…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA places hold on REGENXBIO's Hunter syndrome gene therapy after spinal nodules found, company pauses resubmission
    The FDA placed a clinical hold on RGX-121, REGENXBIO's gene therapy for Hunter syndrome, after MRI scans showed small nodules or cystic masses in the spines of five trial participants. The finding…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • FDA alerts users to destroy AVID Medical IV start kits containing recalled BD ChloraPrep applicators due to fungal contamination risk
    The FDA's Center for Devices and Radiological Health issued an Early Alert warning that certain AVID Medical convenience kits may pose a high‑risk fungal contamination problem because they contain…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA grants three-month extension for Capricor’s Duchenne therapy deramiocel, sets new action date Nov 22
    The U.S. Food and Drug Administration has given Capricor Therapeutics a three‑month extension to review additional data for its Duchenne muscular dystrophy cell therapy, deramiocel. The agency has…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Pharma marketers urged to adopt share-of-answer strategy as AI use surges among physicians
    Pharma marketers are planning for 2027 as artificial intelligence reshapes how clinicians seek clinical answers. The rise of AI tools means that traditional metrics like share of voice and broad om…
    BioPharma Dive · 1d agoNeutral↗ source
  • FDA’s new leadership aims to restore reliability, but each application remains judged on its data
    The FDA’s current leadership is working to rebuild the agency’s reputation for reliability, integrity and transparency after a turbulent period under former commissioner Marty Makary. Recent actio…
    BioSpace · 1d agoRegulatoryNeutral↗ source
  • Vitruvias Therapeutics recalls one lot of 30 mg thyroid tablets over super potency risk
    Vitruvias Therapeutics announced a voluntary recall of a single lot (Lot No. 504950) of its 30 mg thyroid tablets to the consumer level. Testing confirmed the tablets could be superpotent, raising…
    fda medwatch · 1d agoCRLNegative↗ source
  • FDA issues early alert on CooperSurgical infant nasal CPAP devices with loose tubing connection
    The FDA’s Center for Devices and Radiological Health has posted an Early Alert about a potential high-risk issue with certain CooperSurgical infant nasal CPAP devices. The problem involves a loose…
    fda medwatch · 1d agoRegulatoryNegative↗ source
  • FDA alerts to potential fungal contamination in Medline kits containing recalled BD ChloraPrep applicators
    The Center for Devices and Radiological Health (CDRH) has issued an Early Alert to warn the public about a possible high-risk device problem involving Medline convenience kits. Medline has sent a…
    fda medwatch · 1d agoRegulatoryNegative↗ source