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  • Hackers claim to have stolen Novo Nordisk AI models and drug manufacturing recipes, demand $25M ransom
    Novo Nordisk disclosed that a hacker group says it has obtained the company's proprietary AI models and manufacturing recipes for its drugs. The group alleges the data is for sale and has demanded…
    Endpoints · 4mo agoNegative↗ source
  • FDA reverses earlier stance, grants uniQure accelerated approval pathway for Huntington's gene therapy
    On June 17, 2026, the U.S. Food and Drug Administration issued a second reversal, allowing biotech company uniQure to pursue an accelerated approval pathway for its gene therapy targeting Huntingto…
    Endpoints · 4mo agoRegulatoryPositive↗ source
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  • FDA approves first generic single-dose baloxavir tablet for flu treatment and prevention
    FDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…
    fda press · 4mo agoApprovalPositive↗ source
  • Triveni Bio secures $65M Series C as second eczema candidate enters clinical trials
    Triveni Bio announced a $65 million Series C financing round aimed at supporting its ongoing development programs. The round was co‑led by Ascenta Capital and Janus Henderson Investors, with parti…
    Endpoints · 4mo agoDealPositive↗ source
  • Migraine biotech Vedana Therapeutics raises $46 million Series A to advance preclinical pipeline
    Vedana Therapeutics, a new biotech focused on migraine, has announced its emergence from stealth mode after securing a Series A financing round. The company raised $46 million from investors, whic…
    Endpoints · 4mo agoDealPositive↗ source
  • FDA approves OTC naloxone nasal spray Rextovy, expanding consumer access to overdose treatment
    The FDA announced approval of a new over-the-counter naloxone nasal spray called Rextovy, delivering 4 mg of naloxone hydrochloride for emergency reversal of opioid overdose. The product can be pu…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA gives modest backing to Moderna’s flu vaccine, noting efficacy questions but no major concerns
    The FDA released briefing documents ahead of an advisory committee meeting on Moderna’s seasonal influenza vaccine. The agency’s assessment was described as tepid, highlighting some questions abou…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • FDA approves Colorado plan to import lower-cost drugs from Canada
    The U.S. Food and Drug Administration issued a letter confirming that Colorado may move forward with a pilot program to bring prescription medicines from Canada. The proposal aims to lower drug co…
    Endpoints · 4mo agoRegulatoryPositive↗ source
  • Edgewise Therapeutics moves heart disease drug into Phase 3 after updated Phase 2 data
    Edgewise Therapeutics announced on June 16, 2026 that it will advance its investigational therapy for a genetic heart disease into a registrational Phase 3 trial. The decision follows an updated a…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Eli Lilly acquires another pain biotech, its 11th deal this year, as FDA eyes decision on once‑weekly PrEP pill
    Eli Lilly announced the purchase of an Austin, Texas‑based pain biotechnology company, marking the 11th acquisition the Indianapolis‑based firm has completed in 2026. The deal expands Lilly's portf…
    Endpoints · 4mo agoDealNeutral↗ source
  • Health groups accuse HHS of rushing reinstatement of CDC vaccine advisory panel
    A coalition of health organizations has publicly charged the U.S. Department of Health and Human Services with attempting to accelerate the return of the CDC's Advisory Committee on Immunization Pr…
    Endpoints · 4mo agoRegulatoryNegative↗ source
  • UCSF spinout Kopra Bio secures $9.1M to advance virus therapy for glioblastoma in China
    Kopra Bio, a biotechnology company spun out of the University of California, San Francisco, announced it has raised $9.1 million in financing. The capital will be used to move its experimental viru…
    Endpoints · 4mo agoDealPositive↗ source
  • Be Bio halts hemophilia B cell-editing therapy trial
    Be Bio announced that it has terminated its clinical study of a hemophilia B therapy that used gene-editing of a patient’s own cells. The termination was recorded in a federal clinical-trials regi…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • OpenLoop Health says it can launch a virtual GLP-1 prescribing service in 24 hours
    OpenLoop Health says it can set up a telehealth operation that can prescribe GLP-1 medicines within a day. The company provides the medical‑group infrastructure that powers multiple virtual care p…
    Endpoints · 4mo agoNeutral↗ source
  • FDA grants accelerated approval for Tzield to delay insulin loss in children with newly diagnosed Stage 3 type 1 diabetes
    The U.S. Food and Drug Administration issued an accelerated approval on June 12, 2026 for Tzield (teplizumab) to slow the decline of insulin production in pediatric patients aged 8 to 17 who have r…
    fda press · 4mo agoApprovalPositive↗ source
  • CMS proposes rule to close Medicare negotiation loophole for biologics
    CMS announced a proposed policy change that would clarify how the Centers for Medicare & Medicaid Services groups products for price negotiations under the Inflation Reduction Act. The rule target…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • FDA says it will maintain Makary’s focus on clinical trials, rare diseases and China despite leadership exits
    The Food and Drug Administration announced that, even after the recent resignations of Commissioner Marty Makary and the heads of its drug and biologics centers, it will keep pursuing the policy ag…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Takeda releases additional Phase 3 data to bolster its orexin program amid new competition
    Takeda announced new results from its two Phase 3 trials of an orexin‑targeting therapy. The data are intended to demonstrate the drug’s efficacy and safety, reinforcing Takeda’s claim of market‑l…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Elicio Therapeutics’ KRAS pancreatic cancer vaccine fails in Phase 2, stock drops sharply
    Elicio Therapeutics reported that its KRAS‑targeted vaccine for pancreatic cancer did not improve patient outcomes in a mid‑stage (Phase 2) trial. The study results were released in a company state…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Gan & Lee reports positive Phase 3 obesity trial results; J&J shares multiple myeloma data
    Gan & Lee Pharmaceuticals, a China‑based insulin specialist, announced topline results from its Phase 3 obesity trial, indicating a successful outcome. The company said the study met its primary e…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Neumora Therapeutics halts lead depression drug after two more Phase 3 failures, plans 35% staff cuts
    Neumora Therapeutics announced that its lead depression candidate will be discontinued after it did not meet primary endpoints in two additional Phase 3 trials. The company said the data were consi…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • HMNC Brain Health raises $50M Series B to advance two depression drugs
    HMNC Brain Health announced it has closed a $50 million Series B financing round. The capital will be used to move two depression drug candidates into mid-stage clinical trials. The round was led…
    Endpoints · 4mo agoDealNeutral↗ source
  • Lilly showcases Jaypirca combination data in CLL at EHA26, debuting results from Ajax acquisition
    Eli Lilly highlighted new blood‑cancer data at the European Hematology Association meeting in Stockholm. The company presented early clinical results for its Jaypirca therapy combined with the stan…
    Endpoints · 4mo agoNeutral↗ source
  • Six Biopharma Leaders Drive LGBTQ+ Inclusion Amid Rising Anti-LGBTQ Legislation
    Six executives are spearheading initiatives to improve LGBTQ+ inclusion across the biopharmaceutical sector. Their work focuses on creating supportive policies, training programs, and community out…
    Endpoints · 4mo agoNeutral↗ source
  • Biopharma launches nominations for 2025 pay report and highlights Parabilis record IPO
    Endpoints Weekly announced the start of nominations for its eighth annual Women in Biopharma report, aiming to feature 20 distinguished women across science, leadership, and entrepreneurship. The…
    Endpoints · 5mo agoDealNeutral↗ source