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350 stories matching this filter · ← front page

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STAT952Endpoints727BioPharma Dive278BioSpace176Fierce Biotech166onclive165globenewswire health73raps
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allOncology5525Rare Disease1210Cardiology1039Hematology913Immunology903Vaccines787Pulmonology
  • PTC’s $211M bid wins Sangamo auction, teeing up ‘special opportunity’ to enter Fabry market
    PTC Therapeutics has struck a deal to buy Sangamo Therapeutics’ Fabry disease program for $111 million upfront, outbidding Astellas and TerSera Therapeutics for the near-approval gene therapy. Sang…
    Fierce Biotech · 6h ago↗ source
  • Cullinan tees up J&J fight—and $100M payday—as Taiho-partnered drug hits phase 3 cancer goal
    Taiho Pharmaceutical and Cullinan Therapeutics have celebrated a second phase 3 victory for their small-molecule EGFR inhibitor, teeing the partners up to challenge Johnson & Johnson for a lung can…
    Fierce Biotech · 9h ago↗ source
  • Zealand sells its rights to Takeda’s blood cancer drug for $100M ahead of FDA approval decision
    As the FDA mulls whether to approve Takeda and Protagonist Therapeutics’ rusfertide, Zealand Pharma has sold its own rights to the blood cancer drug in return for $100 million.
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fda recalls39
fda medwatch28
fda press24
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Psychiatry & CNS677
Ophthalmology336
Endocrinology & Metabolism335
Pain328
Infectious Disease320
Fierce Biotech · 9h ago↗ source
  • Medtronic veteran Bill Shields crosses over to become CEO at valve disease startup
    After 15 years with Medtronic’s structural heart franchise, Bill Shields is leaving the medtech giant to become the chief executive of startup Versa Vascular.
    Fierce Biotech · 11h ago↗ source
  • AI monitoring tool could generate up to 82-fold ROI in phase-3 oncology trials, study finds
    An analysis by the Tufts Center for the Study of Drug Development found that an artificial-intelligence clinical monitoring agent can produce an estimated 82-fold return on investment in phase-3 on…
    Fierce Biotech · 1d agoPositive↗ source
  • Aardvark Therapeutics abandons phase 3 trials after workforce cuts and FDA hold
    Aardvark Therapeutics announced it is walking away from its recently terminated phase 3 trials, stating there are no plans to resume them as originally designed. The decision follows a reduction i…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • Samsung gets FDA clearance for Galaxy Buds hearing-aid features
    Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests. The hearing tes…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Medline issues correction for convenience kits containing recalled ICU Medical pain management components
    Medline announced a correction for certain convenience kits that include ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection. The FDA classified…
    fda medwatch · 1d agoCRLNegative↗ source
  • FDA issues early alert on non-sterile BD ChloraPrep applicators in Medline convenience kits
    The FDA's Center for Devices and Radiological Health (CDRH) released an early alert about a potential high‑risk issue with certain Medline convenience kits that contain BD ChloraPrep applicators th…
    fda medwatch · 1d agoRegulatoryNeutral↗ source
  • FDA releases proposed commitment letter detailing changes to GDUFA IV program
    The U.S. Food and Drug Administration has issued a proposed commitment letter for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV). The letter follows several months o…
    raps · 1d agoRegulatoryNeutral↗ source
  • Pfizer’s former chemistry whiz debuts Khartis Therapeutics with $95M for thyroid eye disease pill
    Three years after Robert Hoffman sold XinThera to Gilead, the veteran Pfizer chemist has unveiled his latest venture.
    Fierce Biotech · 21h ago↗ source
  • Definium's LSD-based therapy shows strong Phase 3 results in generalized anxiety disorder
    Definium Therapeutics reported that its LSD-derived oral tablet, DT120, met its primary endpoint in a Phase 3 trial for generalized anxiety disorder. The study enrolled over 200 participants and co…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Epicrispr secures $90M Series C to advance epigenetic therapy for rare muscle disease
    Epicrispr Biotechnologies announced a $90 million Series C financing round, led by Octagon Capital and Janus Henderson Investors, with participation from Sanofi Ventures and other investors. The c…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Deerfield-backed Boulevard Bio raises $65 million and unveils three autoimmune drug candidates
    Boulevard Bio, a New York‑based biotech focused on B‑cell biology, announced it has emerged from stealth with $65 million in financing from Deerfield Management. The funding supports the developmen…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Zydus Sentynl signs up to $475M deal to license Mereo's phase-3 ready rare lung disease drug alvelestat in U.S.
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced a licensing agreement with Mereo BioPharma for the U.S. rights to alvelestat, a neutrophil elastase inhibitor that has completed…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 2d agoCRLNegative↗ source
  • Abbott partners with Google Health to add AI-driven insights to its Lingo glucose wearable
    Abbott and Google Health announced a partnership that will combine Abbott's Lingo consumer glucose wearable with Google Health's artificial‑intelligence platform. The integration will let Lingo us…
    Fierce Biotech · 2d agoDealPositive↗ source
  • Amgen to open new R&D Science and Innovation Center in Hyderabad's Genome Valley by 2027
    Amgen announced plans to establish a Science and Innovation Center in Hyderabad's Genome Valley, a biotech hub in India. The facility is slated to open in 2027 and will become part of Amgen's globa…
    Fierce Biotech · 2d agoPositive↗ source
  • Aura Biosciences cuts 20% of staff and reshuffles C-suite to focus on ocular oncology
    Aura Biosciences announced it is eliminating about one-fifth of its workforce as part of a broader restructuring under its new chief executive officer, Natalie Holles, who took the helm in April.…
    Fierce Biotech · 2d agoLayoffsNeutral↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 2d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 2d agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 2d agoRegulatoryNeutral↗ source
  • After tasting IPO success, Hemab’s CEO seeks ‘flavor of a multi-product coagulation company’
    With the post-IPO quiet period having come to an end, CEO Benny Sørensen, M.D., Ph.D., was free to sit down with Fierce to map out Hemab’s future.
    Fierce Biotech · 2d ago↗ source
  • FDA issues early alert after BD needle set defects linked to four deaths
    The FDA’s Center for Devices and Radiological Health released an early alert warning clinicians to stop using Becton Dickinson’s intraosseous vascular access needle sets after reports of serious in…
    Fierce Biotech · 3d agoRegulatoryNegative↗ source