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  • AAM warns that price pressures threaten sustainability of US generics and biosimilars market
    The Association for Accessible Medicines (AAM) issued its annual report warning that the economics of off‑patent drugs have deteriorated, putting the sustainability of the generic and biosimilar ma…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Scholar Rock receives FDA approval for Isembyld, first muscle-targeted SMA therapy
    Scholar Rock announced that its monoclonal antibody apitegromab, branded Isembyld, has been cleared by the FDA for treatment of spinal muscular atrophy (SMA). The approval follows a previous rejec…
    BioSpace · 1mo agoApprovalPositive↗ source
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  • BioNTech's CTLA-4 antibody gotistobart shows 8.5-month survival boost in previously treated lung cancer patients
    BioNTech reported new data on its CTLA-4 targeting antibody gotistobart in lung cancer. The study focused on patients whose disease had progressed after prior therapy. Those receiving gotistobart…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • BioNTech's anti-CTLA-4 drug shows survival advantage in advanced squamous lung cancer at WCLC
    BioNTech, together with partner OncoC4, presented new overall survival data at the World Conference on Lung Cancer in South Korea, joining other companies such as Summit Therapeutics, GSK and Roche…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Scholar Rock receives FDA approval for apitegromab (Isembyld) to treat spinal muscular atrophy
    Scholar Rock announced FDA approval for its injectable drug apitegromab, marketed as Isembyld, for treating spinal muscular atrophy, a rare muscle-wasting condition. The approval follows earlier s…
    Endpoints · 1mo agoApprovalPositive↗ source
  • FDA seeks external input on rare disease trial criteria and endpoint selection
    The FDA announced it will seek additional external feedback as it reviews how to evaluate efficacy and safety data for rare disease therapies. The agency noted the difficulty of setting appropriat…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • GSK reports 94% response rate for Jideytro in ROS1-positive lung cancer at World Conference
    GSK is moving a newly acquired lung-cancer drug, Jideytro, toward FDA review after presenting data at the World Conference on Lung Cancer. The conference data showed a 94% response rate when Jidey…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Sanofi-backed Electra Therapeutics targets $297 million IPO as Enhertu shows Phase 3 lung cancer success
    Electra Therapeutics, a biotech company supported by Sanofi, announced plans to raise roughly $297 million through an initial public offering. The firm hopes to launch the offering shortly after La…
    Endpoints · 1mo agoDealPositive↗ source
  • Definium's LSD candidate DT120 shows positive Phase 3 results, moving toward FDA submission
    Definium Therapeutics reported positive topline data from its Phase 3 Panorama trial of DT120, an oral LSD formulation for generalized anxiety disorder (GAD). The trial met its primary endpoint, s…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Novo drops Nordisk from name, rebrands as Novo with new bull logo
    Novo Nordisk announced it will drop the "Nordisk" part of its name, rebranding simply as Novo and rotating the iconic Apis bull in its logo to signal a new direction. CEO Mike Maziar Doustdar said…
    BioSpace · 1mo agoNeutral↗ source
  • AstraZeneca's Etcamah fails late-stage trial for early-stage breast cancer use
    AstraZeneca announced that its newly approved breast cancer therapy, Etcamah, did not meet its primary goals in a pivotal study aimed at expanding the drug's label. The trial evaluated Etcamah in…
    Endpoints · 1mo agoNegative readoutNegative↗ source
  • Definium Therapeutics reports positive Phase 3 results for oral LSD anxiety drug DT120
    Definium Therapeutics announced Monday that its experimental oral LSD formulation, DT120, achieved positive outcomes in a Phase 3 trial targeting an anxiety disorder. The trial, the company's thir…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Public backing fuels FDA hearing on psychedelic therapies and potential COMP360 approval
    The FDA is holding a hearing on Monday to discuss the future of psychedelic drug development, after a wave of public comments expressed strong support for further research. Analysts say the suppor…
    BioSpace · 1mo agoRegulatoryPositive↗ source
  • Merck and Moderna’s melanoma vaccine success spurs five rivals to chase personalized cancer vaccine breakthrough
    Merck and Moderna announced that their mRNA‑based cancer vaccine, given together with Merck’s Keytruda, extended progression‑free survival in patients with cutaneous melanoma in a late‑stage trial.…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • FDA appoints new oncology chief, pledges ongoing innovation; approves treatments for two rare genetic disorders
    The Food and Drug Administration has announced a new leader for its Oncology Center of Excellence. The appointee emphasized a continued focus on innovative cancer therapies and collaborative resear…
    raps · 1mo agoRegulatoryPositive↗ source
  • Singapore moves forward with legislation for a more coherent, future-ready healthcare regulatory system
    Singapore's Parliament has taken a step toward overhauling its healthcare regulatory framework by advancing new legislation. The proposed law aims to create a more coherent and future-ready system…
    raps · 1mo agoRegulatoryPositive↗ source
  • Cyclic peptide drugs gain traction as AI and hybrid synthesis aim to overcome manufacturing hurdles
    Oral cyclic peptides are attracting attention because they promise the convenience of small‑molecule drugs while delivering antibody‑like selectivity, a combination that is fueling interest after t…
    BioSpace · 1mo agoNeutral↗ source
  • EMA says regulators pledge API inspection sharing but report modest progress
    The European Medicines Agency reports that regulators worldwide are strongly committed to sharing plans for good manufacturing practice inspections of active pharmaceutical ingredient suppliers. D…
    raps · 1mo agoRegulatoryNeutral↗ source
  • RAPS Convergence 2026 Highlights Future of Regulatory Science and Patient Safety
    The RAPS Convergence 2026 event gathered regulatory professionals to reflect on how the field has changed. Attendees discussed how emerging technologies are reshaping regulatory processes and expe…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA issues new guideline on assessing gastrointestinal drug interaction risks
    The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract. The document focuses on extrinsic factors such…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Biopharma firms urged to boost visibility with podcasts, webinars and thought-leadership programs
    The guide released by BioSpace Insights outlines how biopharma communication teams can use emerging channels to raise their profile. It notes that while traditional media remains important, podcas…
    BioSpace · 1mo agoNeutral↗ source
  • Novo Nordisk rebrands as 'Novo' and launches new culture strategy after recent setbacks
    Novo Nordisk announced it will drop "Nordisk" from its public brand, opting to be known simply as "Novo" starting Monday. The name change is part of a broader cultural overhaul aimed at revitalizi…
    Endpoints · 1mo agoNeutral↗ source
  • Sino Biological launches site-specific labeled proteins to aid cell surface research
    Cell surface proteins play key roles in immune signaling, cell adhesion and tissue maintenance, making them important targets for therapies and diagnostics. Researchers need reliable tools to dete…
    BioSpace · 1mo agoPositive↗ source
  • Centric Compounding recalls Glutathione, Myer’s Cocktail and Tri-Immune Boost injectables over elevated endotoxin levels
    Centric Compounding LLC announced a voluntary recall of six lots of its injectable products Glutathione 200 mg/mL, Myer’s Cocktail and Tri-Immune Boost. The recall was issued on September 9, 2026 a…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Akeso and Summit report survival advantage for PD-1xVEGF combo over Keytruda
    At the American Society of Clinical Oncology (ASCO) 2026 meeting, Akeso Biopharma and its partner Summit Therapeutics announced new survival results for their experimental PD‑1×VEGF bispecific anti…
    Endpoints · 1mo agoPositive readoutPositive↗ source