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1,245 stories matching this filter · ← front page

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  • 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 · 2h agoApprovalPositive↗ source
  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 2h agoApprovalPositive↗ source
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Infectious Disease376
  • Haisco Pharmaceutical partners with ARCH Venture Partners and Population Health in new China-focused deal
    Haisco Pharmaceutical, a China-based drugmaker, has continued its active summer dealmaking by striking a new partnership. The partnership brings together ARCH Venture Partners, a venture capital f…
    Endpoints · 2h agoDealPositive↗ source
  • OmicsBank secures $2.25M to expand overseas patient data platform for biopharma
    OmicsBank announced it has closed a $2.25 million financing round aimed at scaling its platform that aggregates patient health data from overseas sources for use by biopharma companies. The compan…
    Endpoints · 4h agoDealPositive↗ 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 · 13h agoRegulatoryNegative↗ source
  • Bristol Myers Squibb ends partnership with Cellares, prompting the cell therapy maker to restructure
    Bristol Myers Squibb announced that it is terminating its collaboration with Cellares after completing a comprehensive evaluation of the partnership. The decision was driven by BMS’s assessment th…
    Endpoints · 5h agoDealNegative↗ source
  • Founded by Metsera backers, Sentivera emerges with $1.5B inflammatory disease deal
    Having set Metsera on its journey to a $10 billion takeover, Arch Venture Partners and Population Health Partners have powered their new startup—Sentivera—to a licensing deal worth up to $1.5 billion.
    Fierce Biotech · 7h ago↗ source
  • Implantica finally nabs FDA approval 8 years after EU green light for reflux implant
    The FDA has signed off on Implantica’s gastroesophageal reflux disease (GERD) implant as the medtech eyes a lucrative U.S. market.
    Fierce Biotech · 11h ago↗ 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 · 1d 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 · 1d agoDealPositive↗ source
  • TwinStrand wins patent lawsuit as GSK’s hepatitis B therapy receives Japanese approval
    TwinStrand Biosciences, a DNA sequencing spin‑out from the University of Washington, announced it has prevailed in a patent infringement lawsuit against a California‑based competitor. The court’s…
    Endpoints · 1d agoApprovalPositive↗ 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 · 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
  • 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 · 19h agoPositive↗ source
  • DC judge dismisses Merck's challenge to Medicare drug price negotiations
    A Washington D.C. federal judge rejected Merck's lawsuit contesting Medicare drug price negotiations under the Inflation Reduction Act. Judge Colleen Kollar-Kotelly of the U.S. District Court for t…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Regenxbio faces second FDA clinical hold, delaying Hunter syndrome gene therapy filing
    Regenxbio announced that its gene therapy for Hunter syndrome has received a second clinical hold from the FDA this year. The company said it no longer expects to submit an NDA or seek approval in…
    Endpoints · 1d agoRegulatoryNegative↗ source
  • Roche commits $190 million upfront to license Hanmi's early-stage muscle-building obesity drug, total deal up to $2.3 billion
    Roche announced it will pay $190 million upfront to license an early-stage obesity drug from South Korean company Hanmi Pharm. The compound is described as a non-incretin, muscle-building therapy a…
    Endpoints · 1d agoDealPositive↗ source
  • Option-to-acquire structures stay uncommon amid biotech's busy M&A season
    Biotech companies are experiencing one of the busiest deal-making years on record, with a flood of announced mergers and acquisitions. Two recent transactions have highlighted the option-to-acquir…
    Endpoints · 1d agoDealNeutral↗ 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 · 1d 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 · 1d 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 · 1d agoRegulatoryPositive↗ 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
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry input on competency-based rules for generative AI medical devices
    The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence. The agency says the approac…
    raps · 1d agoRegulatoryNeutral↗ source