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30 May 2014 | By Sanofi
Sanofi and its subsidiary Genzyme announced that the U.S. Food and Drug Administration has accepted for review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada...
29 May 2014 | By Boehringer Ingelheim
Boehringer Ingelheim announced that the company has reached a comprehensive settlement of state and federal cases in the U.S. litigation regarding Pradaxa®...
16 May 2014 | By Novartis
Novartis announced that the US Food and Drug Administration has issued a Complete Response Letter regarding the Biologics License Application for RLX030...
15 May 2014 | By Novartis
Novartis Pharmaceuticals Corporation has settled its litigation with the United States subsidiary of Sun Pharmaceutical Industries Ltd. relating to Novartis patents covering the use of certain polymorphic forms of Gleevec®...
14 May 2014 | By The European Medicines Agency
The European Commission and the US Department of Health and Human Services have published a progress report of the Transatlantic Taskforce on Antimicrobial Resistance...
8 May 2014 | By Johnson & Johnson
Filing Includes data from treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis...
6 May 2014 | By H. Lundbeck A/S
H. Lundbeck A/S announced that clinical and pre-clinical data highlighting the company’s ongoing commitment to advancing the science and treatment of depression will be presented at the American Psychiatric Association 167th Annual Meeting...
6 May 2014 | By Teva
Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has approved SYNRIBO® (omacetaxine mepesuccinate) for injection...
6 May 2014 | By AstraZeneca
AstraZeneca announced that the US Food and Drug Administration has approved EPANOVA (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridaemia...
1 May 2014 | By Nova Laboratories
UK pharmaceutical firm Nova Laboratories has secured U.S Food and Drug Administration approval for its acute lymphoblastic leukaemia (ALL) product Xaluprine...
30 April 2014 | By Teva
Data provides promise for a twice-daily, acetaminophen-free hydrocodone designed with potential abuse-deterrent properties...
25 April 2014 | By Roche
Expanded indication makes cobas HPV Test the only test approved in U.S. that can be used instead of Pap in first-line primary screening in women 25 and older...
16 April 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the US Food and Drug Administration has approved TanzeumTM (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes...
14 April 2014 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company announced the submission of a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate...
10 April 2014 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir...
