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Pharma News for GSK, Roche, Eli Lilly, Coherus
Phase III RUBY Trial of Jemperli Plus Chemotherapy Updates; FDA Approves Roche’s Vabysmo for RVO; FDA Grants Priority Review to Tovorafenib Low-Grade Glioma; FDA Approves Lilly’s Omvoh; FDA Approves Toripalimab for Nasopharyngeal Carcinoma; FDA Fast Track Designation to ONCT-534 R/R mCRPC

FDA Granted Fast Track Designation to Oncternal Therapeutics’s ONCT-534 for the Treatment of Metastatic Castration-Resistant Prostate Cancer On Oct. 26, 2023, Oncternal Therapeutics, Inc. (Nasdaq: ONCT) announced that the U.S. Food and Drug Administration (FDA) has designated ONCT-534, its novel dual-acting andr...

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Pharma News for XORTX, Roche, Lantheus, Janssen, Daiichi Sankyo, bluebird bio, and POINT Biopharma Global
Janssen’s AKEEGA Approval; FDA Approves Roche’s Polivy Combo for Frontline B-cell Lymphoma; Daiichi Sankyo’s Quizartinib for Adults With FLT3-ITD-Positive AML; bluebird bio BLA for lovo-cel for Patients with Sickle Cell Disease; Fast Track Designation for Lu-PNT2002 for mCRPC Treatment; FDA Orphan Drug Designation to XORTX’s Oxypurinol

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) had granted marketing authorization for AKEEGA® (niraparib and abiraterone acetate [AA]), in the form...

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pharma-news-for-accutar-bio-thera-nykode-heat-biologics-elusys
Accutar’s Phase I clinical trial for AC0176; Bio-Thera’s cancer drug, BAT6005; Nykode’s Covid-19 vaccine trial; Heat Biologics acquires Elusys

FDA approves IND application of Accutar for a prostate cancer treatment trial The US Food and Drug Administration (FDA) has granted Accutar Biotechnology’s Investigational New Drug (IND) application for Phase I clinical trial of AC0176 for treating metastatic castration-resistant prostate cancer (mCRPC). An i...

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