Group items tagged

PBR Staff Writer Published 25 February 2014 Bristol-Myers Squibb (BMS) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).

PBR Staff Writer Published 24 February 2014 US-based biotechnology firm Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) of its Kalydeco (ivacaftor) for the treatment of people with cystic fibrosis (CF).

GSK submits sNDA for Promacta to FDA for severe aplastic anaemia treatment

US-based Edison Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for its lead drug EPI-743 to treat patients with Friedreich's ataxia.

Germany-based pharmaceutical firm Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for Pradaxa (dabigatran etexilate) to treat venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE).

The US Food & Drug Administration (FDA) has granted fast track designations for both the intravenous (IV) and oral formulations of Tetraphase Pharmaceuticals' lead antibiotic candidate, eravacycline.

GSK has received approval from FDA for its Tanzeum subcutaneous injection to improve glycemic control, along with diet and exercise, in adult patients with type 2 diabetes.

PBR Staff Writer Published 01 May 2014 The US Food and Drug Administration (FDA) has approved GlaxoSmithKline's (GSK) Incruse Ellipta (umeclidinium) for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Umeclidinium is a once-daily long-acting muscarinic antagonist (LAMA), a type of bronchodilator also known as an anticholinergic.

PBR Staff Writer Published 21 February 2014 Israel-based Pluristem Therapeutics has submitted its application to the US Food and Drug Administration seeking Orphan Drug Designation for its PLacental eXpanded (PLX-PAD) cells for the treatment of severe preeclampsia.

US-based KYTHERA Biopharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin.