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  • Epicrispr and Infinimmune secure $165 million in venture funding for epigenetic and antibody programs
    Epicrispr Biotechnologies announced a $90 million Series C round to push its epigenetic therapy program for facioscapulohumeral muscular dystrophy (FSHD). The lead candidate, EPI-321, is in a firs…
    BioSpace · 2h agoDealPositive↗ source
  • Hims & Hers says it can quickly launch six wellness peptides if FDA lifts ban
    Hims & Hers used its second‑quarter earnings call to explain that it is preparing to offer six consumer wellness peptides that are currently prohibited for compounding pharmacies. The company says…
    Endpoints · 1h agoRegulatoryPositive↗ source
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  • Scholar Rock pulls Indiana fill-finish plant from SMA therapy filing after FDA flags violations
    Scholar Rock has removed Novo Nordisk's former Catalent fill‑finish facility in Bloomington, Indiana, from its regulatory filing for a spinal muscular atrophy therapy after the FDA classified the p…
    BioSpace · 1h agoRegulatoryNegative↗ source
  • Former Legend Biotech chief Ying Huang named CEO of K2, targets $250 million Series A to license Asian assets
    Ying Huang spent the past seven years building one of the leading cancer cell‑therapy companies before stepping down as CEO of Legend Biotech. Weeks after announcing his departure, Huang has taken…
    Endpoints · 2h agoDealPositive↗ source
  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 3h agoDealPositive↗ source
  • Medicare’s new $50 GLP‑1 weight‑loss drug program may create barriers for patients, warns experts
    Medicare has launched a program that caps out‑of‑pocket costs for GLP‑1 weight‑loss medicines such as Wegovy, Zepbound and Foundayo at $50 a month for eligible beneficiaries. The initiative is inte…
    STAT · 5h agoRegulatoryNegative↗ source
  • Austria launches up to €100 million anchor investment for growth fund, aiming to channel half‑billion euros into biotech
    Austria's government announced a new national Startup & Scaleup Fund as part of the 2027/2028 budget, with an anchor investment of up to €100 million. The public money is designed to attract priva…
    BioSpace · 7h agoPositive↗ source
  • Nurses voice concerns on AI while regulators outline RAPID pathway for breakthrough devices
    The latest STAT Health Tech newsletter, dated August 11, 2026, highlights two contrasting developments in health technology. Nurses interviewed for the piece express skepticism about the impact of…
    STAT · 1h agoRegulatoryNeutral↗ source
  • Silence causes uproar in rare blood cancer space as data sets high bar for competitors
    The mid-stage win of Silence Therapeutics’ siRNA drug in polycythemia vera validates the therapeutic approach of similar assets in development—but also sets a high standard for therapies from Taked…
    BioSpace · 3h agoRegulatoryNeutral↗ source
  • Nonprofit North Star Review Board offers independent model to fix IRB oversight issues
    Founders Stephen Rosenfeld and Patricia Seymour created the not‑for‑profit North Star Review Board after becoming disillusioned with the current system of institutional review boards (IRBs) that ov…
    STAT · 5h agoRegulatoryNeutral↗ source
  • Nurses push for involvement as AI threatens jobs and patient care
    Nurses, the largest segment of the health‑care workforce, are increasingly vocal about the risks that clinical artificial intelligence poses to their employment and to patient safety. At Montefior…
    STAT · 5h agoNegative↗ source
  • Abortion care shifts to remote and private channels as patients seek help outside clinics
    Patients are increasingly turning to non‑clinical avenues for abortion information, a trend that began before the Dobbs decision. A family physician recounts a recent encrypted message from a teena…
    STAT · 5h agoNeutral↗ source
  • FDA rejects ITM Isotope’s radiopharma therapy over manufacturing issues
    ITM Isotope Technologies plans on resubmitting its advanced cancer radiopharma therapy to the FDA after addressing the agency’s concerns.
    BioSpace · 20m ago↗ source
  • STAT+: Pharmalittle: We’re reading about an FDA rejection, 340B court battles, and more
    The FDA rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis
    STAT · 49m ago↗ source
  • Epicrispr secures $90M after early data on epigenetic FSHD treatment
    Epicrispr Biotechnologies has raised $90 million for its Series C round after sharing promising early data around a potential new way to treat a rare muscle disease called facioscapulohumeral muscu…
    Endpoints · 1h ago↗ source
  • After billions in deals, Insilico CEO promises: ‘You haven't seen anything yet’
    Insilico Medicine CEO Alex Zhavoronkov’s mad dash across the BIO International Convention in June attracted plenty of eyes. But the executive would prefer industry watchers gawk at the billions of…
    BioSpace · 2h ago↗ source
  • STAT+: Skylark Bio kicks off new gene therapy trial for deafness
    Biotech startups in the U.S., France, and China are racing to bring new gene therapies for deafness by targeting different genetic mutations.
    STAT · 2h ago↗ source
  • AbCellera’s menopause medicine ‘sets new efficacy bar’ for hot flashes
    AbCellera Biologics’ reduction in hot flashes sets it apart from currently commercial oral drugs, including Astellas’ Veozah and Bayer’s Lynkuet, according to BMO Capital Markets.
    BioSpace · 3h ago↗ source
  • Vaderis fuels up with $152M series B to test rare vascular disease in Phase 3
    Vaderis is hoping that engasertib will become the first approved medicine for hereditary hemorrhagic telangiectasia, a rare condition that can cause spontaneous bleeding.
    BioSpace · 3h ago↗ source
  • STAT+: Why is MoonLake Immunotherapeutics scared of releasing data on its drug candidate?
    Biotech companies don’t hide or obfuscate strong data.
    STAT · 5h ago↗ source
  • Tenax Therapeutics' heart failure drug TNX-103 misses primary endpoint in Phase 3, shares plunge 85%
    Tenax Therapeutics announced that its investigational heart failure drug TNX-103 failed to meet the primary efficacy endpoint in the Phase 3 LEVEL trial. The trial, which enrolled patients with pu…
    BioSpace · 1d agoNegative readoutNegative↗ source
  • Eli Lilly's $3.8 B acquisition of AtaiBeckley signals growing confidence in psychedelics for depression
    Psychedelics are being touted as a potential solution for patients who still struggle to find lasting relief from existing FDA‑approved psychiatric medicines. The article notes that many individual…
    BioSpace · 1d agoDealPositive↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 22h agoPositive readoutPositive↗ source
  • FDA advisory panel set to review Grail’s multi-cancer Galleri screening test
    An FDA advisory committee is scheduled to evaluate Grail’s Galleri blood test, which is designed to detect a range of cancers at an early stage. The panel will examine the test’s clinical data, pe…
    STAT · 23h agoRegulatoryNeutral↗ source
  • Jazz Pharma to acquire Actio Biosciences for up to $1.3 billion, adding experimental KCNT1 epilepsy drug
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, paying $820 million in cash with up to $500 million in milestone payments. The deal is expected to close by the end of the year.…
    BioSpace · 23h agoDealPositive↗ source