December 9, 2015
FDA nods for Vonvendi for von Willebrand disease
The U.S. Food and Drug Administration on Tuesday approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of…
Pharmaceuticals, Biotechnology and Life Sciences
Category: Approval
December 4, 2015
India’s Sun Pharmaceutical enters $2.5B US market with its generic version of Gleevec
Sun Pharmaceutical Industries, largest India-based generic pharmaceutical companies, has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Novartis’ Gleevec.
November 30, 2015
Janssen asks for its Chron’s disease drug Stelara U.S. and EU approval
Janssen Biotech, Inc. and Janssen-Cilag International NV (Janssen) are seeking approval from the U.S. and European authorities for Chron’s disease drug Stelara.
November 30, 2015
European Commission approves Horizon’s Ravicti for treating Urea Cycle Disorders
Horizon Pharma and its affiliate, Horizon Therapeutics, has gotten the European Commission’s (EC’s) approval for Ravicti – glycerol phenylbutyrate – Oral Liquid for use as an adjunctive therapy for chronic management patients with six subtypes of Urea Cycle Disorders (UCDs).
November 27, 2015
EU opens door for Impax’s Parkinson’s treating oral capsule Numient
Impax Laboratories has been granted by the European Commission (EC) authorization to market its Numient oral capsule formulation for the symptomatic treatment of adult patients with Parkinson’s disease.
November 24, 2015
Lilly’s lung cancer drug in combo with gemcitabine and cisplatin gets FDA’s OK
Eli Lilly has gotten the U.S. Food and Drug Administration (FDA) approval for cancer drug Portrazza, which comes in a form of injection for intravenous use, 800 mg/50 mL, in combination with gemcitabine and cisplatin.
November 24, 2015
Lupin gets a go-ahead to market Blisovi – generic version Warner Chilcott’s Loestrin tablets – in U.S.
US FDA has given Lupin a go to market Blisovi Fe 1/20 Tablets and Blisovi 1.5/30 Tablets market generic versions of Warner Chilcott’s Loestrin Fe 1/20 Tablets and Loestrin Fe 1.5/30 Tablets.
November 24, 2015
Futura Medical’s two painkillers cleared path for Europe
Futura Medical, a transdermal technology specialist, has received by an European regulator clarity on the regulatory pathways for its two topical pain relief products, TPR100 (diclofenac) and TIB200 (ibuprofen).
November 24, 2015
Novartis’ heart failure tablet Entresto available in EU
European Commission has approved Switzerland-based Novartis’ Entresto tablets for treating adult patients with symptomatic chronic heart failure with reduced ejection fraction.
November 24, 2015
Bristol-Myres Squid’s Opdivo gets FDA’s nod (kidney cancer)
The U.S. Food and Drug Administration has approved Bristol-Myers Squibb-marketed Opdivo (nivolumab) to treat patients with advanced form of kidney cancer.