Category Regulatory

Sumitomo Pharma Reports TWYMEEG® Q4 2024 Sales and Full-Year Forecast in Japan

Poxel SA and Sumitomo Pharma: A Closer Look at TWYMEEG®’s Sales Performance and Strategic Growth Initiatives In the rapidly evolving landscape of metabolic disease treatments, Poxel SA (Euronext: POXEL – FR0012432516) stands out as a pioneering clinical-stage biopharmaceutical company. With…

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New Data Shows DCT Components Enhance Clinical Trial Access for Underrepresented Communities

New Study Shows DCT Components Boost Diversity, But Gaps Remain for Black Participants DCT Components, The lack of diversity in clinical trials has been a persistent issue, with racial, ethnic, and gender disparities often leaving underrepresented communities excluded from critical…

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ImmunityBio & BeiGene Launch Phase 3 Trial for ANKTIVA® and PD-1 Inhibitor in NSCLC

ImmunityBio, Inc. (NASDAQ: IBRX) has announced a strategic collaboration and supply agreement with BeiGene, Ltd. (soon to be renamed BeOne Medicines, Ltd.), a global oncology company. The partnership will focus on conducting a confirmatory, randomized Phase 3 clinical trial (ResQ201A-NSCLC),…

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FDA Approves Lilly’s Omvoh for Crohn’s Disease, Expanding Use in Inflammatory Bowel Disease

Eli Lilly and Company has announced that the U.S. FDA has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults. This approval marks a significant milestone for the company, as Omvoh is now approved…

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Datopotamab Deruxtecan Receives Priority Review for Advanced EGFR+ NSCLC

Datopotamab Deruxtecan Granted Priority Review by FDA for Advanced EGFR-Mutated NSCLC AstraZeneca and Daiichi Sankyo recently announced that the U.S. Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd). This development marks a…

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Biologics License Grifols Submits Application to U.S. FDA for Innovative Fibrinogen Solution

Biologics License Grifols Advances Fibrinogen Solution with U.S. FDA Submission Biologics License Grifols a global healthcare company and leading manufacturer of plasma-derived medicines, has announced the submission of a Biologics License Application (BLA) for its innovative fibrinogen treatment to the…

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Osteosarcoma Breakthrough GSK’s B7-H3 ADC GSK’227 Gains FDA Breakthrough Designation

GSK Receives FDA Breakthrough Therapy Designation for GSK5764227 in Osteosarcoma Treatment GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for GSK5764227 (GSK’227), its targeted antibody-drug conjugate (ADC) designed to treat…

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