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756 stories matching this filter · ← front page

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  • FDA grants emergency use authorization for Simparica TRIO to treat New World screwworm in dogs and puppies
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Simparica TRIO, a chewable tablet containing sarolaner, moxidectin and pyrantel, to treat New World screwworm infesta…
    fda press · 6d agoRegulatoryPositive↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics
    K2 Therapeutics announced that Ying Huang, who recently left his role as CEO of Legend Biotech, will now lead the young biotech company. The appointment comes just weeks after Legend announced Huan…
    Fierce Biotech · 6d agoNeutral↗ source
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Infectious Disease346
  • 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 up the partners to challenge Johnson & Johnson in a lung canc…
    Fierce Biotech · 7d agoNeutral↗ source
  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 7d agoPositive readoutPositive↗ 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 · 7d agoPositive↗ source
  • Former Pfizer chemist launches Khartis Therapeutics with $95M to develop oral thyroid eye disease drug
    Robert Hoffman, a veteran Pfizer chemist who previously co‑founded XinThera, announced the launch of Khartis Therapeutics. The new company, formed in 2024 with other former XinThera leaders, aims t…
    Fierce Biotech · 7d agoDealPositive↗ source
  • Silence Therapeutics' Phase 2 trial shows strong results for divesiran in polycythemia vera, shares jump 30%
    Silence Therapeutics reported that its nucleic‑acid drug divesiran achieved a 69% placebo‑adjusted response rate in a Phase 2 study of polycythemia vera patients. Safety was reported as clean, with…
    BioPharma Dive · 7d agoPositive readoutPositive↗ source
  • Boulevard Bio launches with $65 million to develop bispecific antibodies for IgA nephropathy and other autoimmune diseases
    Boulevard Bio, a new biotech co-founded by autoimmune researcher Georg Schett and former Sanofi CSO Frank Nestle, announced its launch on Wednesday with $65 million in funding. The company’s first…
    BioPharma Dive · 7d agoDealPositive↗ 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 · 7d 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 · 8d agoApprovalPositive↗ source
  • Eli Lilly sues to curb black-market sales of experimental obesity drug retatrutide
    Eli Lilly announced it has filed six new lawsuits aimed at stopping black-market sales of its experimental obesity medicine retatrutide. The legal actions target online merchants, clinics, compound…
    BioPharma Dive · 7d agoRegulatoryNegative↗ 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 · 8d 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 · 8d agoPositive readoutPositive↗ source
  • Epicrispr raises $90 million to push epigenetic editing drug EPI-321 for rare muscle disorder FSHD
    Epicrispr Biotechnologies announced a $90 million Series C financing to accelerate development of its epigenetic editing therapy EPI-321 for facioscapulohumeral muscular dystrophy (FSHD), a rare ge…
    BioPharma Dive · 8d agoDealPositive↗ 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 · 8d agoDealPositive↗ source
  • Hemab Therapeutics IPO raises $301.5M, stock triples and funds runway to 2029
    Hemab Therapeutics completed an upsized $301.5 million IPO in May, boosting total proceeds to $346.7 million. The offering helped the company’s share price climb from $18 at debut to $53.48 by mid‑…
    Fierce Biotech · 8d agoDealPositive↗ source
  • Infinimmune secures $75 million Series A to develop longer-lasting eczema antibody therapies
    Infinimmune, a biotech based in Alameda, California, announced on Tuesday that it has closed a $75 million Series A financing round. The capital will support the development of its first two clinic…
    BioPharma Dive · 8d 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 · 8d agoDealPositive↗ source
  • Trump signs executive order to split MMR vaccine and reduce U.S. childhood immunization schedule
    President Donald Trump signed an executive order on Monday that calls for a reduced U.S. childhood vaccine schedule, lowering the number of universally recommended shots from 17 to 11. The order d…
    BioPharma Dive · 8d agoRegulatoryNegative↗ 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 · 8d agoDealPositive↗ 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 · 9d agoDealPositive↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics as startup secures $50M seed funding
    Ying Huang, who led Legend Biotech for seven years and helped develop a top‑selling cell therapy for multiple myeloma, has been named chief executive of K2 Therapeutics. The young company, founded…
    BioPharma Dive · 8d 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 · 8d agoPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 8d agoDealPositive↗ 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 · 9d agoLayoffsNeutral↗ source