Pharmaceuticals, Biotechnology and Life Sciences
Vectura Group confirmed on Thursday what its partner Hikma Pharmaceuticals said in its interim results statement about its abbreviated new drug application (ANDA) filing for a US generic version of Advair Diskus.
The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.
FDA has published 48 finalized product-specific guidances describing its current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.
Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.
The US Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for acalabrutinib, a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor, developed by AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma. This potential new medicine is in development for the treatment of multiple B-cell and other cancers.
Ablynx was granted Fast Track designation for caplacizumab, by the that the U.S. Food and Drug Administration (FDA). That’s the company’s first-in-class anti-von Willebrand factor (vWF) Nanobody developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).
HedgePath Pharmaceuticals said on Tuesday that the U.S. Food and Drug Administration (FDA) has provided further guidance regarding HPPI’s ongoing, open-label Phase 2 clinical trial studying the effect of SUBA-Itraconazole (SUBA-Cap) oral capsules in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome.
The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.
The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.
The U.S. Food and Drug Administration on Tuesday approved Gildad’s Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir.