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652 stories matching this filter · ← front page

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  • Baxter recalls two lots of 0.9% Sodium Chloride Injection over possible fiberglass particles
    Baxter International announced a voluntary recall of two batches of its 0.9% Sodium Chloride Injection after detecting potential fiberglass particles in the solution. The company said the particul…
    fda medwatch · 17d agoCRLNegative↗ source
  • Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System after sheath tip separation reports
    Boston Scientific announced a recall of its ENROUTE Transcarotid Neuroprotection System and the ENROUTE Transcarotid Neuroprotection System Plus. The FDA classified the recall as the most serious…
    fda medwatch · 17d agoCRLNegative
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Infectious Disease456
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  • UCSF maps over 1,800 protein interactions linked to autism, revealing new drug target opportunities
    UCSF scientists created a molecular map of autism by analyzing 100 risk genes, which uncovered more than 1,800 protein-protein interactions. The study found that about 87% of these connections had…
    Fierce Biotech · 16d agoPositive↗ source
  • Biotech entrepreneur Someit Sidhu launches JATT III Acquisition SPAC with $60M Nasdaq IPO
    Someit Sidhu, M.D., announced the formation of JATT III Acquisition, a new special purpose acquisition company that raised $60 million in an initial public offering on Nasdaq. The SPAC will seek t…
    Fierce Biotech · 17d agoDealNeutral↗ source
  • Industry groups call for clearer FDA guidance on QRIs in expedited IND pilot
    Pharmaceutical trade groups have voiced concerns about the FDA's proposed expedited IND pilot, which aims to speed entry of drug candidates into first‑in‑human studies. The groups say the FDA need…
    raps · 17d agoRegulatoryNeutral↗ source
  • McKesson to acquire Precision Medicine Group for $2.25 billion, boosting oncology capabilities
    McKesson, a Fortune 500 healthcare wholesaler, announced a $2.25 billion acquisition of privately held Precision Medicine Group. The deal will fold Precision into McKesson's oncology and multispec…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Sentivera secures up to $1.5 billion licensing deal for inflammatory disease candidate
    Sentivera, a biotech startup formed by investors behind Metsera, announced a licensing agreement with Shanghai-listed Haisco Pharmaceutical. Under the deal, Sentivera will pay Haisco $40 million u…
    Fierce Biotech · 18d agoDealPositive↗ source
  • Implantica receives FDA approval for RefluxStop GERD implant after eight years since EU launch
    Implantica announced that the U.S. Food and Drug Administration has granted approval for its gastroesophageal reflux disease (GERD) implant, RefluxStop, following a rigorous Premarket Approval revi…
    Fierce Biotech · 18d agoApprovalPositive↗ source
  • FDA grants Capricor three-month extension to review DMD cell therapy data
    The U.S. Food and Drug Administration has given Capricor Therapeutics an additional three months to evaluate its Duchenne muscular dystrophy cell therapy after the agency asked for more information…
    Fierce Biotech · 18d agoRegulatoryNegative↗ source
  • FDA expands labels for J&J’s Imaavy and Jazz’s Ziihera; Teva under Turkish antitrust probe
    The U.S. Food and Drug Administration has broadened the approved uses for Johnson & Johnson’s oncology drug Imaavy and Jazz Pharmaceuticals’ Ziihera, adding new indications to each label. These la…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on potency testing for immunotherapy products
    The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a draft guidance document aimed at helping sponsors evaluate potency assays for active immunotherapy products (ACTIMPs). Th…
    raps · 18d agoRegulatoryNeutral↗ source
  • FDA issues warning letters to drugmakers in China, India and the US over GMP violations
    The U.S. Food and Drug Administration has issued warning letters to a number of manufacturers in China, India and the United States. The letters cite multiple violations of good manufacturing prac…
    raps · 18d agoRegulatoryNegative↗ source
  • Inhalable modified tRNA restores lung protein function in cystic fibrosis mice, shows promise for genetic diseases
    University of Toronto scientists have shown that an inhalable form of modified transfer RNA can safely reach the lungs of mice carrying a nonsense mutation that causes cystic fibrosis. The treatmen…
    Fierce Biotech · 17d agoPositive readoutPositive↗ source
  • Labcorp introduces reflex hepatitis D test to improve detection of severe viral hepatitis
    Labcorp has launched a new hepatitis D (HDV) reflex testing option as part of its Comprehensive Hepatitis Testing portfolio, aiming to close a gap in HDV monitoring. The test automatically adds HD…
    Fierce Biotech · 17d agoPositive↗ source
  • FDA issues warning letters to drug manufacturers in India, China and US over GMP violations
    The FDA has sent formal warning letters to several companies located in India, China and the United States. The letters cite multiple breaches of current good manufacturing practice standards in t…
    raps · 18d agoRegulatoryNegative↗ source
  • Frontier Medicines CEO vows to accelerate cancer drug pipeline after recent layoffs
    Frontier Medicines announced that after a restructuring that included layoffs last year, the company is refocusing on its AI-driven proteomics platform to push more cancer therapies into clinical t…
    Fierce Biotech · 17d agoPositive↗ source
  • Roche and Eli Lilly receive FDA clearance for first blood test detecting Alzheimer’s biomarker pTau217
    Roche and Eli Lilly have secured FDA clearance for a new blood test that measures phosphorylated tau protein pTau217, a marker linked to amyloid plaques in Alzheimer’s disease. The Elecsys pTau217…
    Fierce Biotech · 19d agoApprovalPositive↗ source
  • Roche signs $2.5 billion deal with Hanmi for experimental obesity drug targeting muscle loss
    Roche's Genentech unit has agreed to acquire global rights (outside South Korea) to Hanmi's clinical-stage urocortin-2 analog, HM17321, as part of a deal valued up to $2.5 billion. The agreement i…
    Fierce Biotech · 19d agoDealPositive↗ source
  • FDA places clinical hold on Regenxbio’s RGX-121 gene therapy after spine MRI findings, delaying refiling plans
    The U.S. Food and Drug Administration has issued a clinical hold on Regenxbio’s gene therapy candidate RGX-121 after routine MRI scans revealed asymptomatic changes in the spines of trial participa…
    Fierce Biotech · 19d 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 · 19d agoRegulatoryNegative↗ source
  • Massachusetts biotech sees record-first-half VC funding and IPO surge despite modest NIH funding dip
    The latest MassBio Industry Snapshot reports a strong start to 2026 for the state’s biotech sector, with venture capital inflows rising 25% year over year to $3.45 billion in the first half of the…
    Fierce Biotech · 18d agoPositive↗ source
  • Qiagen names Jonathan M. Pratt as new chief executive after nine-month search
    Qiagen announced that Jonathan M. Pratt will take over as chief executive, ending a nine‑month search for a successor. Pratt arrives from Filtration Group, where he served as president and CEO. He…
    Fierce Biotech · 19d agoNeutral↗ source
  • TME Pharma narrows licensing talks for brain-cancer drug NOX-A12, eyes $1 billion market
    TME Pharma, a German biotech, says it has narrowed potential partners for its experimental glioblastoma therapy NOX-A12, a CCL2 inhibitor, to two firms and entered a final evaluation phase. The co…
    Fierce Biotech · 19d agoDealNeutral↗ source
  • Spruce Biosciences advances toward Q4 FDA filing for ultra-rare Sanfilippo B therapy
    Spruce Biosciences reported progress toward filing its enzyme replacement therapy, tralesinidase alfa (TA-ERT), for Sanfilippo syndrome type B, an ultra-rare lysosomal disorder. The company said t…
    Fierce Biotech · 19d agoRegulatoryPositive↗ 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 · 19d agoCRLNegative↗ source