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Solid Biosciences has entered into a non-exclusive global license & collaboration agreement with Kinea Bio to develop & commercialize KNA-155 for treating dysferlin-related limb-girdle muscular dystrophy, using Solid’s AAV-SLB101 capsid…
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The CHMP has recommended Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, ankylosing spondylitis & ulcerative…
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The US FDA has accepted sBLA & granted priority review to Enhertu + Perjeta for the 1L treatment of adults with unresectable or metastatic HER2+ breast cancer, which will be reviewed…
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BMS has reported the P-III (EXCALIBER-RRMM) trial data assessing iberdomide + daratumumab + dexamethasone (IberDd) vs daratumumab + bortezomib + dexamethasone (DVd) in pts with r/r multiple myeloma
The trial…
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Variational AI has entered into a collaboration with Merck to design and optimize novel small molecule candidates against two undisclosed targets using Variational AI’s Enki platform
As per the…
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The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries
Opinion was…
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PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA
The August 2025…
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Angelini Pharma has entered into an exclusive global option agreement with Sovargen to develop & commercialize SVG105 for the treatment of brain health disorders
As per the deal, Angelini…
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Starpharma has entered into a collaboration & license agreement with Genentech to develop dendrimer-drug conjugates incorporating Genentech’s drugs for oncology targets, leveraging Starpharma’s DEP drug delivery tech
As per…