The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations.
Novartis today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. Tafinlar in combination with Mekinist is in development to become the first adjuvant treatment specifically for melanoma patients with a BRAF V600 mutation.
GlaxoSmithKline plc announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 50 years and older. Shingrix is a non-live, recombinant subunit vaccine given intramuscularly in two doses.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained.
Kite, a Gilead Company, announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma.
The FDA has approved a second chimeric antigen receptor (CAR) T-cell therapy for cancer: Kite Pharma's axicabtagene ciloleucel (Yescarta) for the treatment of certain types of refractory large B-cell lymphoma, the agency announced.
AstraZeneca announced that the FDA has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
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