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  • Health tech investors shift focus to larger funding rounds, Cityblock secures $116 million
    Throughout the past year, investors in digital health have increasingly favored megafunding rounds rather than smaller seed or Series A deals. In August, community-health startup Cityblock announc…
    Endpoints · 1mo agoDealPositive↗ source
  • Akeso's ivonescimab shows survival advantage over Keytruda in Chinese lung cancer trial
    A new data cut from a study comparing ivonescimab, a bispecific antibody from China-based Akeso, with Merck's Keytruda in patients with non-small cell lung cancer was released. The interim results…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
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  • FDA requests public input to accelerate botanical drug product development
    The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward. Botanical drug products are derived from pl…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Superluminal Medicines raises $60M Series B to launch Phase 1 trial of genetic obesity therapy
    Superluminal Medicines, a Boston‑based biotech, announced it has closed a $60 million Series B financing round. The capital will fund the company’s first‑in‑human study of its genetic obesity candi…
    Endpoints · 1mo agoDealNeutral↗ source
  • Ultragenyx's Angelman syndrome drug fails Phase 3 trial, halting development
    Ultragenyx reported that its experimental antisense oligonucleotide designed for Angelman syndrome did not meet primary endpoints in a Phase 3 study. The trial, which enrolled patients with the ra…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 1mo agoDealNeutral↗ source
  • Novartis licenses Alteogen’s hyaluronidase enzyme ALT-B4 in new drug delivery partnership
    Novartis announced a licensing agreement with South Korean biotech Alteogen to use its hyaluronidase enzyme ALT-B4 for drug delivery applications. The enzyme will be produced using Alteogen’s prop…
    Endpoints · 1mo agoDealNeutral↗ source
  • Deaths of two Chinese children receiving CRISPR therapy spark safety debate
    Two children in China died after receiving experimental CRISPR-based gene therapies, according to a recent report. The fatalities have unsettled researchers in the United States who are developing…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Novartis CAR-T trial deaths spark safety concerns for autoimmune applications
    Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Novartis and Bristol Myers pause autoimmune CAR-T trials after serious safety events
    Novartis and Bristol Myers Squibb announced the suspension of several autoimmune CAR‑T studies after encountering serious safety problems. In Novartis' trials, three participants died from a severe…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev
    A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
    Endpoints · 1mo agoApprovalPositive↗ source
  • UniQure files FDA priority review request for Huntington’s gene therapy AMT-130
    UniQure, a Dutch biotech, announced on Wednesday that it has submitted applications to the U.S. Food and Drug Administration seeking a priority review for its gene therapy AMT-130, which targets th…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval
    The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency. T…
    Endpoints · 1mo agoRegulatoryNegative↗ source
  • Teva's experimental antibody cuts intestinal damage in celiac patients after gluten challenge
    Teva reported that a single injection of an experimental antibody markedly lowered intestinal damage in participants with celiac disease who continued to consume gluten daily. The study was a glut…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Teva reports positive mid-stage results for celiac disease antibody, BioMarin settles patent fight with Ascendis
    Teva said its experimental antibody TEV-408 showed statistically significant and clinically meaningful reduction in gluten-induced intestinal damage in a mid-stage trial for celiac disease. The tr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Typewriter secures $56M to advance jumping-gene platform and in vivo CAR-T therapies
    Typewriter, a biotech startup, announced it has closed a $56 million financing round. The capital will be used to develop its jumping-gene platform, which seeks to deliver full genes without viral…
    Endpoints · 1mo agoDealPositive↗ source
  • Alumis' TYK2 inhibitor flunks mid-stage lupus trial, shares drop 55%
    Alumis reported that its experimental TYK2 inhibitor, envudeucitinib, failed to meet any primary or secondary endpoints in a mid-stage study of systemic lupus erythematosus. The company highlighte…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 1mo agoCRLNegative↗ source
  • Novartis reports Phase 3 success for MS pill remibrutinib, beats Aubagio and shows no liver safety issues
    Novartis announced that its BTK inhibitor remibrutinib met primary endpoints in two Phase 3 trials in patients with relapsing multiple sclerosis. The studies showed the drug reduced annualized rel…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • GSK to begin Phase 3 trial of mRNA seasonal flu vaccine after strong Phase 2 results
    GSK announced it will start a Phase 3 study of its mRNA vaccine targeting seasonal influenza. The move follows Phase 2 data that showed the candidate produced higher immune responses than traditio…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Novartis' Rhapsido shows safety edge and relapse reduction in Phase 3 multiple sclerosis trials
    Novartis reported results from two identical Phase 3 studies of its BTK inhibitor Rhapsido in patients with multiple sclerosis. The trials showed the oral pill lowered the annualized relapse rate…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • ARPA-H grants up to $125M to accelerate on-demand custom RNA therapy manufacturing
    ARPA-H announced a new funding initiative aimed at speeding the creation of personalized RNA medicines. The agency will provide up to $125 million in total awards. Five research groups were select…
    Endpoints · 1mo agoDealPositive↗ source
  • Eli Lilly's 2026 acquisitions boost over 50 biotech venture investors
    Eli Lilly announced its thirteenth acquisition of 2026, continuing a busy year of dealmaking for the drugmaker. The transactions have involved at least fifty different venture capital firms, sendi…
    Endpoints · 1mo agoDealPositive↗ source