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868 stories matching this filter · ← front page

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  • FDA approves first generic weekly hormone patch for menopausal women
    The U.S. Food and Drug Administration has granted approval for a generic version of a once‑weekly transdermal hormone patch that combines estradiol and levonorgestrel. The product matches the brand…
    fda press · 2h agoApprovalPositive↗ source
  • FDA releases final guidance on prescription-drug companion apps and software
    FDA issued final guidance that creates a clear framework for how drug makers can develop, distribute and label mobile applications that accompany prescription medicines. The document answers three…
    fda press · 5h agoRegulatoryNeutral↗ source
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  • Rapport Therapeutics' Phase 2 Bipolar Mania Trial Meets Primary Endpoint, Though Effect Size Below Target
    Rapport Therapeutics reported that its phase 2 study of RAP-219 in bipolar mania met the primary endpoint, showing a statistically significant improvement on the Young Mania Rating Scale (YMRS) at…
    Fierce Biotech · 9h agoPositive readoutNeutral↗ source
  • EY report says MedTech growth driven by commercial leaders, AI and expanding into new care settings
    The latest EY Pulse of the MedTech Industry report looks at the period from 2025 through the first half of 2026. It finds that innovation has spurred more dealmaking and R&D spending, while artific…
    Fierce Biotech · 14h agoPositive↗ source
  • Pfizer halts phase 2 trial of CXCR5 antibody for immune thrombocytopenia
    Pfizer announced it is ending a phase 2 study of its CXCR5-targeting antibody PF-06835375 in patients with primary immune thrombocytopenia (ITP). The decision was described as a business decision a…
    Fierce Biotech · 14h agoCRLNegative↗ source
  • AstraZeneca partners with Oracle to boost clinical trial patient recruitment using AI
    AstraZeneca announced a collaboration with data-technology firm Oracle to apply artificial-intelligence tools to clinical-trial recruitment. The non-binding agreement will let the partners explore…
    Fierce Biotech · 16h agoDealPositive↗ source
  • Lycia Therapeutics targets $228M IPO to fund food allergy protein degrader programs
    Lycia Therapeutics announced plans for an initial public offering expected to raise about $228 million. The proceeds are intended to support its pipeline of protein degrader therapeutics targeting…
    Fierce Biotech · 10h agoDealNeutral↗ source
  • Disc spins past FDA rejection with ‘overwhelmingly positive’ phase 3 data for rare disease drug
    A phase 3 trial of Disc Medicine’s bitopertin has hit both co-primary endpoints and all secondary endpoints, positioning the biotech to refile for approval of the once-rejected rare disease drug ca…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Roche signs $15 billion ADC partnership with China's Hansoh Pharma
    Roche has re-entered a partnership with China's Hansoh Pharmaceutical, signing a $15 billion biobucks agreement. The deal covers a broad portfolio of antibody-drug conjugate programs, including tw…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Israeli biotech's inhaled exosome therapy cuts respiratory failure and mortality in ARDS phase 2b trial
    Nano24, an Israeli biotech company, tested its inhaled exosome product EXO‑CD24 in a mid‑stage study involving 90 patients with acute respiratory distress syndrome. The trial compared the therapy,…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA Grants Accelerated Approval for Jemperli Immunotherapy in Locally Advanced Rectal Cancer
    The U.S. Food and Drug Administration has granted accelerated approval for a new use of the immunotherapy Jemperli (dostarlimab‑gxly). The approval applies to adults with previously untreated stage…
    fda press · 1d agoApprovalPositive↗ source
  • AbbVie’s combo of Skyrizi and trosunilimab shows higher remission than Skyrizi alone in phase 2 Crohn’s trial
    AbbVie tested a next‑generation Crohn’s disease regimen by randomizing 300 patients with moderate‑to‑severe disease to receive Skyrizi, the α4β7 inhibitor trosunilimab, or the two drugs together (c…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Merck acquires Silence Therapeutics for $1.3B; Hansoh Pharma signs $15B deal with Roche
    German Merck announced the acquisition of Silence Therapeutics in a transaction valued at $1.3 billion. In China, Hansoh Pharma disclosed a partnership with Roche that involves a $15 billion drug…
    raps · 1d agoDealNeutral↗ source
  • Eli Lilly teams with Hong Kong's Metis TechBio in up to $1.1 billion AI nanoparticle partnership
    Eli Lilly has entered a partnership with Hong Kong‑based Metis TechBio to access an artificial‑intelligence driven platform for designing lipid nanoparticles that can improve drug delivery. The co…
    Fierce Biotech · 1d agoDealPositive↗ source
  • TCGX uses SPAC to take migraine biotech TriGemX public, securing $246M for phase-3 trial
    TCGX, a life‑sciences investment firm, announced it will merge its SPAC with TriGemX Bio, a biotech focused on migraine treatments. TriGemX, formerly known as Kallyope, is developing a TRPM8 chann…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Gilead reports positive Phase 2 results for oral ulcerative colitis drug
    Gilead announced that its experimental oral therapy for ulcerative colitis achieved positive results in a Phase 2 trial. The study reported that patients receiving the drug showed measurable clini…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Enlivex cuts 60% of staff, halts preclinical R&D and slashes exec salaries to fund osteoarthritis trial
    Enlivex, an Israeli biotech developing a cell‑based immunotherapy called allocetra for knee osteoarthritis, announced today that it is reducing its workforce by 60 percent. The cut reduces the sta…
    Fierce Biotech · 1d agoLayoffsNegative↗ source
  • Merck KGaA buys Silence in $1.3B deal after siRNA drug's phase 2 blood cancer win
    Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo.
    Fierce Biotech · 1d agoDealNeutral↗ source
  • Siemens Healthineers teams with Paradromics to develop multimodal imaging platform for brain-computer interfaces
    Siemens Healthineers and Paradromics announced a collaboration to build an advanced multimodal imaging system designed to support implantable brain‑computer interfaces (BCIs). The partnership combi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Japan’s PMDA releases guidance on evaluating generative AI-enabled medical devices
    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of review points aimed at medical devices that incorporate generative artificial intelligence. The guidance outlines th…
    raps · 1d agoRegulatoryNeutral↗ source
  • MedTech firms grow more comfortable with FDA's Quality Management System Regulation amid inspection concerns
    At The MedTech Conference in Boston, a senior industry executive reported that the medtech sector is gradually accepting the new Quality Management System Regulation (QMSR) despite early worries.…
    raps · 1d agoRegulatoryNeutral↗ source
  • Labcorp to acquire BioReference Health assets for $722M cash
    Labcorp and OPKO Health announced an agreement in which Labcorp will purchase select assets of BioReference Health, a subsidiary of OPKO. The assets include laboratory testing businesses focused o…
    Fierce Biotech · 2d agoDealPositive↗ source
  • China drafts policy to block foreign buyouts of key cell-gene therapy and siRNA platforms
    China’s government has released a draft amendment to its export blacklist that would prohibit or tightly control foreign purchases of certain biopharmaceutical platforms. The rule targets propriet…
    Fierce Biotech · 4d agoRegulatoryNegative↗ source
  • Nouscom secures €120M to advance off-the-shelf cancer vaccine for Lynch syndrome
    Swiss biotech Nouscom announced a €120 million (about $135 million) Series D financing round. The capital will fund a registration-enabling pivotal trial of its cancer-preventing vaccine candidate.…
    Fierce Biotech · 4d agoDealPositive↗ source
  • FDA issues warning letters to drug makers over CGMP lapses and highlights patient rep ties to industry-backed groups
    The FDA has issued warning letters to several drug manufacturers for failing to meet current good manufacturing practice requirements, citing problems with ensuring product sterility and meeting sp…
    raps · 4d agoRegulatoryNegative↗ source