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  • JATT mastermind launches latest biotech-focused SPAC via $60M IPO
    Just two months after Someit Sidhu, M.D., succeeded in pairing off his second special purpose acquisition company (SPAC) with Talawar Therapeutics, the biotech entrepreneur is back at it again.
    Fierce Biotech · 5h ago↗ source
  • Boston Scientific hit by cyberattack causing ‘disruptions’ to parts of its business
    This year has seen a growing number of medtechs hit by cyberattacks, and now Boston Scientific has become the latest victim.
    Fierce Biotech · 7h ago↗ source
  • Spyre’s rheumatoid arthritis plan toppled by subpar TL1A data
    Phase 2 data on Spyre Therapeutics’ anti-TL1A antibody SPY072 in rheumatoid arthritis have fallen short of expectations, prompting the biotech to deprioritize monotherapy development in the indicat…
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fda recalls53
fda medwatch46
fda press29
933
Psychiatry & CNS757
Ophthalmology455
Pain422
Endocrinology & Metabolism400
Infectious Disease380
Fierce Biotech · 9h ago
↗ source
  • SK Biopharma pens $795M deal to usher Biohaven’s epilepsy therapy towards hoped-for 2029 launch
    SK Biopharmaceuticals has strengthened its epilepsy offering by paying $350 million upfront to help speed Biohaven’s Kv7 ion channel activator on its way to market.
    Fierce Biotech · 10h ago↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 20h agoApprovalPositive↗ source
  • 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 · 1d 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 · 1d agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 1d agoRegulatoryPositive↗ 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 · 1d 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 · 1d agoApprovalPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 17h agoDealNeutral↗ source
  • Trump-era health funding cuts reshape U.S. health system, prompting Medicaid coverage changes
    STAT’s D.C. Diagnosis newsletter examines how recent Republican health‑care funding cuts are altering the nation’s health‑care safety net. The series, led by Washington correspondent John Wilkerson…
    STAT · 1d agoRegulatoryNeutral↗ source
  • 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 · 1d agoDealPositive↗ source
  • Haisco partners with US VCs to launch immunology biotech Sentivera with up to $1.5B funding
    Haisco Pharmaceutical Group announced the creation of a new immunology-focused biotech called Sentivera, backed by two American venture‑capital firms, Population Health Partners and ARCH Venture Pa…
    BioSpace · 1d agoDealPositive↗ source
  • Turkish antitrust regulator launches probe into Teva for alleged patent manipulation and false claims about rivals
    Turkish competition authorities have opened an investigation into Teva Pharmaceutical, the world’s largest generic drugmaker, accusing the company of manipulating the patent system and making misle…
    STAT · 1d agoRegulatoryNegative↗ 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 · 1d agoDealPositive↗ source
  • Trump’s Medicaid cuts strain rural hospitals in Maine and Louisiana
    President Trump’s administration has slashed about $1 trillion from projected Medicaid funding over the next ten years and let billions in insurance subsidies expire, prompting a rapid reassessment…
    STAT · 1d agoRegulatoryNegative↗ source
  • Curium seeks FDA review of rival radioligand therapy to boost supply resilience against Novartis' Pluvicto
    Curium is preparing to challenge Novartis' dominant prostate cancer radioligand therapy, Pluvicto, by entering discussions with the FDA about reviewing its own PSMA‑directed Lu‑177 candidate. Nova…
    BioSpace · 1d agoRegulatoryNeutral↗ 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 · 1d agoRegulatoryNegative↗ source
  • Sword Health to acquire mental-health platform Headspace in cash deal slated for September 14
    Sword Health, a digital health firm best known for its AI‑driven virtual physical therapy, has filed to purchase mental‑health service provider Headspace. The regulatory filing indicates the trans…
    STAT · 18h agoDealNeutral↗ source
  • Amgen and academic centers discuss FDA pilot to accelerate first-in-human trials
    The U.S. Food and Drug Administration is working with industry and research institutions on a pilot program aimed at speeding first-in-human studies. The effort is intended to counter the rapid tim…
    Endpoints · 20h agoRegulatoryNeutral↗ source
  • Two unvaccinated Pennsylvanians die from measles, marking first US deaths this year
    Two unvaccinated residents of Lancaster County, Pennsylvania have died from measles, the first measles-related deaths reported in the United States this year. State Health Secretary Dr. Debra Boge…
    STAT · 23h agoNegative↗ source
  • Massachusetts biotech workforce rebounds after 2025 decline
    A new report from the Massachusetts Biotechnology Council shows the state’s biopharma employment fell by about 3,600 workers in 2025, marking the first drop since at least 2002. The workforce tota…
    STAT · 1d agoPositive↗ source
  • FDA pledges new guidance for generative AI medical devices as Epic shares updates from its user conference
    The Food and Drug Administration released a discussion paper outlining its plans to regulate generative‑AI‑powered medical devices. The agency said it will issue formal guidance to clarify how exis…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Bausch + Lomb moves dry-eye eye drop to Phase 3 despite missing primary endpoint in Phase 2
    Bausch + Lomb reported results of a Phase 2 trial of its dual-action dry-eye eye drop, which combines 5% lifitegrast (the active ingredient in Xiidra) with perfluorohexyloctane (PHFO, sold as Miebo…
    BioSpace · 1d agoNegative readoutNeutral↗ source