Category Regulatory

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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FDA Grants Groundbreaking Pioneering Approval for Opdivo Qvantig Injection in 5 Adult Solid Tumor Indications

Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) Injection for subcutaneous use. This innovative combination product includes nivolumab, an immunotherapy agent, co-formulated with recombinant human hyaluronidase…

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Lilly and EVA Pharma Announce Regulatory Approval and Launch of Locally Manufactured Insulin in Egypt

The Egyptian Drug Authority has granted regulatory approval for insulin glargine injection manufactured by EVA Pharma in collaboration with Eli Lilly and Company. This approval marks a significant milestone in the partnership that was launched in 2022, aiming to provide…

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