Gilead Company’s subsidiary Kite has received the US Food and Drug Administration (FDA) approval for the commercial production at its new CAR T-cell therapy manufacturing facility in Maryland.
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Merck’s tepmetko (tepotinib) to treat adult patients with advanced non-small cell lung cancer (NSCLC).
The European Commission (EC) has approved Astellas and Seagen’s padcev (enfortumab vedotin-ejfv) for the treatment of urothelial cancer, a bladder cancer type.
Glenmark Pharmaceuticals’ subsidiary Glenmark Specialty has received the Drugs Controller General of India (DCGI) approval to initiate the Phase I clinical trial of its new small-molecule, GRC 54276, in advanced solid tumours and Hodgkin's lymphoma patients.
Novartis has secured accelerated approval from the US Food and Drug Administration (FDA) for vijoice (alpelisib) to treat PIK3CA-related overgrowth spectrum (PROS) patients.
The US Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals and Sanofi’s Dupixent (dupilumab) supplemental Biologics License Application (sBLA) for priority review.
Everest Medicines has submitted a new drug application (NDA) in Hong Kong for sacituzumab govitecan (SG) to treat metastatic triple-negative breast cancer (mTNBC).
Abionyx Pharma has received orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) to the Bio-HDL CER-001 to treat lecithin-cholesterol acyltransferase (LCAT) deficiency.
The US Food and Drug Administration (FDA) has approved UCB’s Fintepla (fenfluramine) oral solution CIV to treat two years and above aged patients who have seizures associated with Lennox-Gastaut syndrome (LGS), a rare childhood epilepsy form.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Roche’s Polivy (polatuzumab vedotin) and MabThera (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) combination to treat lymphoma.
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