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  • Lilly leads GLP-1 weight-loss market while Novo Nordisk’s Wegovy exceeds expectations but falls short of forecasts
    Eli Lilly and Novo Nordisk are intensifying their battle for dominance in the multibillion‑dollar GLP‑1 weight‑loss market, with each company promoting its own set of injectable therapies and pipel…
    BioPharma Dive · 5h agoEarningsNeutral↗ source
  • US lawmakers push FDA to tighten rules on Chinese clinical data after three gene therapy deaths
    Three recent deaths in separate gene‑therapy trials in China have prompted two members of the U.S. House of Representatives to call on the FDA for new safeguards. Representatives John Moolenaar an…
    BioSpace · 1h agoRegulatoryNegative↗ source
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  • Novo Nordisk launches Phase 3 trial of lower maintenance doses of oral Wegovy for obesity
    Novo Nordisk has begun a Phase 3, placebo-controlled study called OASIS 5 to evaluate two lower oral doses of its GLP-1 weight-loss drug Wegovy (semaglutide) in people who are obese or overweight.…
    BioSpace · 4h agoCRLNeutral↗ source
  • Werewolf and Ambros to tie the knot in $150M rare disease deal
    The merger, which would create a new company bearing Ambros’ name, will help support development of Ambros' non-opioid painkiller for patients with debilitating limb injuries.
    BioSpace · 1h ago↗ source
  • Shareholder pressures Capricor; Lilly dives deeper into vaccines
    Kaos Capital wants a “governance reset” to alter the Duchenne cell therapy maker’s strategic course. Elsewhere, Bristol Myers furthered efforts to build an “AI-powered” discovery engine.
    BioPharma Dive · 2h ago↗ source
  • Werewolf transforms into Ambros via reverse merger to support phase 3 push for rare disease drug
    Werewolf Therapeutics’ hunt for strategic alternatives has ended. Ambros Therapeutics has agreed to merge with Werewolf in an all-stock deal and raised $150 million, positioning the biotech to take…
    Fierce Biotech · 6h ago↗ source
  • Moderna’s melanoma vaccine trial success sparks $45 billion market value surge
    Moderna’s shares jumped more than 170% after the company announced that its experimental melanoma vaccine, intismeran, met its primary goals in a Phase 3 trial. The surge added roughly $45 billion…
    BioPharma Dive · 1d agoPositive readoutPositive↗ source
  • Merck and Moderna’s melanoma vaccine shows positive Phase 3 results, boosting investor confidence
    Merck and Moderna announced that their personalized melanoma vaccine met the primary endpoint of recurrence‑free survival in a Phase 3 trial when given together with Keytruda. The study showed pati…
    BioSpace · 1d agoPositive readoutPositive↗ source
  • Moderna's cancer vaccine boost lifts stock, sparks talk of Keytruda-like reach
    Moderna’s shares surged 177% after a phase 3 topline win for its Merck‑partnered cancer vaccine, intismeran autogene, was disclosed. The data, released on Wednesday, added roughly $45 billion to Mo…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA clears Vitestro's Aletta, first robotic blood draw device for U.S. clinics
    The U.S. Food and Drug Administration has granted clearance to Vitestro's Aletta, making it the first standalone robotic system approved to draw blood without direct human handling. Aletta can per…
    Fierce Biotech · 1d agoApprovalPositive↗ source
  • Roche commits $750 million to double Oregon plant capacity as obesity drug push grows
    Roche's Genentech announced a $750 million investment to enlarge its device fill-finish facility in Hillsboro, Oregon. The expansion will double the plant's size and add end-to-end capabilities fo…
    BioSpace · 20h agoDealPositive↗ source
  • Scribe Therapeutics’ early-stage IPO surges 43% as epigenetic cholesterol drug enters clinic
    Scribe Therapeutics filed for an IPO while its lead epigenetic therapy moves into early clinical testing, a rare combination in a market that prefers later-stage, de-risked offerings. The company…
    BioSpace · 1d agoPositive↗ source
  • Regeneron secures FDA approval for Pasatru, second U.S. treatment for rare bone disease FOP
    Regeneron received FDA approval for its antibody garetosmab, marketed as Pasatru, for treatment of fibrodysplasia ossificans progressiva (FOP) in adults. The approval makes Pasatru the second ther…
    BioSpace · 1d agoApprovalPositive↗ source
  • Layoffs hit over 1,300 workers across seven biopharma M&A deals in 2026
    Workforce reductions this year have affected at least seven biopharma companies that recently completed mergers or acquisitions, eliminating a minimum of 1,359 jobs, according to BioSpace data. Th…
    BioSpace · 1d agoLayoffsNegative↗ source
  • Trump nominates Heidi Overton as FDA Commissioner as agency releases CGT Q&A guidance
    The U.S. Food and Drug Administration issued final guidance that answers common questions about developing cellular and gene therapy products. The document aims to clarify regulatory expectations f…
    raps · 1d agoRegulatoryNeutral↗ source
  • Ultragenyx secures FDA approval for Glenglycos, first gene therapy for GSD Ia
    Ultragenyx announced FDA approval of Glenglycos, a one-time gene therapy for glycogen storage disease type Ia, a rare genetic disorder. The therapy delivers a functional gene to the liver to resto…
    BioPharma Dive · 1d agoApprovalPositive↗ source
  • Ultragenyx secures first gene therapy approval for GSDIa as Sanfilippo asset decision pending
    Ultragenyx received accelerated FDA approval for its gene therapy DTX401, marketed as Genglycos, to treat glycogen storage disease type Ia (GSDIa). The approval comes as the company awaits a secon…
    BioSpace · 1d agoApprovalPositive↗ source
  • Chai Discovery partners with Bristol Myers Squibb to use AI for antibody discovery
    Chai Discovery, an AI-driven drug discovery company, announced a collaboration with Bristol Myers Squibb to apply its artificial-intelligence models to therapeutic antibody research. The partnershi…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Eli Lilly partners with Amplitude Therapeutics to develop trans-amplifying RNA vaccines for infectious diseases
    Eli Lilly announced a collaboration with Boston-based Amplitude Therapeutics, a company that emerged from Lilly’s Gateway Labs incubator. The partnership will focus on developing trans-amplifying…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Biotech firms EMD Serono and Exelixis cut remote R&D staff as they enforce office return policies
    Biopharma workers at two biotech companies are losing jobs as employers shift away from remote work. The changes affect research and development staff who were previously allowed to work from home.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • FDA approves Ultragenyx gene therapy for glycogen storage disorder; Overton faces confirmation hurdles
    The U.S. Food and Drug Administration has granted approval to Ultragenyx's gene therapy aimed at treating a glycogen storage disorder. This marks a regulatory milestone for the company and the rare…
    raps · 1d agoApprovalPositive↗ source
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 23h agoApprovalPositive↗ source
  • Experts discuss persistent CMV challenges and new antiviral approaches for transplant patients
    In a recent episode of BioSpace's Denatured podcast, Ian McGowan, chief medical officer of Synklino, and James Hunter, an associate professor of transplantation at Oxford University, joined host Je…
    BioSpace · 1d agoNeutral↗ source
  • Pediatric rare cancer research draws steady investment despite biotech market volatility
    The article notes that pediatric rare cancers continue to attract investment because they address the greatest unmet medical needs and allow clear measurement of patient impact. Even as the biotec…
    BioSpace · 1d agoPositive↗ source
  • Pheast Therapeutics sticks with open R&D despite competitor Antengene moving ahead with anti‑CD24 trials
    Pheast Therapeutics, a Redwood City biotech founded in 2021, builds on Irv Weissman’s 2019 Nature paper that highlighted the CD24 protein as a promising "don’t eat me" target for cancer immunothera…
    Fierce Biotech · 1d agoNeutral↗ source