The US Food and Drug Administration (FDA) has granted fast track designation (FTD) for Priothera’s mocravimod and allogeneic Hematopoietic Stem Cell Transplant (HSCT) combination for post remission therapy of Acute Myeloid Leukemia (AML) patients.
The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) for priority review in adults with prurigo nodularis.
The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ biologics license application (BLA) for a biosimilar to Neulasta, pegfilgrastim-pbbk.
Novartis has received approval from the European Commission (EC) for its oral therapy Jakavi (ruxolitinib) to treat patients aged 12 years and above with acute or chronic graft-versus-host disease (GvHD).
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.
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