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.
Just as GlaxoSmithKline nears a decision from the U.S. FDA for its key shingles vaccine, Shingrix, Canada has become the first country to approve the shot—and it's a key piece of CEO Emma Walmsley's prescription for growth at the drugmaker.
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.
Back in April, England’s cost watchdogs said they wouldn’t cover Bristol-Myers Squibb’s Opdivo in head and neck cancer due to “uncertain” clinical evidence. Now, though, they’re singing a different tune.
Boehringer Ingelheim announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 21 (L861Q), G719X or S768I substitution mutations as detected by an FDA-approved test.
Dutch biotech UniQure has won orphan drug designation (ODD) for its investigational treatment for Huntington’s Disease, a rare, inherited neurodegenerative disorder that leads to loss of muscle coordination, behavioural abnormalities and cognitive decline.
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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