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15 July 2014 | By Actavis
Actavis plc confirmed that it has filed an Abbreviated New Drug Application with the FDA seeking approval to market Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release tablets...
15 July 2014 | By Roche
Roche announced that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer...
14 July 2014 | By Teva
First breath-actuated dry-powder SABA inhaler to be accepted by FDA for review...
9 July 2014 | By Actavis
Actavis plc confirmed that it has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Dalfampridine Extended-release Tablets, 10 mg...
9 July 2014 | By Boehringer Ingelheim
Results from a Phase II study, published in the American Society of Hematology journal Blood, showed patients with previously untreated acute myeloid leukemia aged 65 or older and ineligible for intensive remission induction therapy, lived longer...
8 July 2014 | By Sanofi
Sanofi announced that the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application for Toujeo®...
30 June 2014 | By Boehringer Ingelheim
The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to the investigational antidote idarucizumab...
26 June 2014 | By AstraZeneca
AstraZeneca today announced that the US Food and Drug Administration Oncologic Drugs Advisory Committee voted 11 to 2 that current evidence from clinical studies does not support an accelerated approval for use of olaparib...
25 June 2014 | By Merck
If approved, fixed-dose combination would be used with other antiretroviral agents for the treatment of HIV-1 in adults, adolescents and certain pediatric patients...
19 June 2014 | By H. Lundbeck A/S
Lundbeck will present results about sexual functioning from a head-to-head study of Brintellix® (vortioxetine) vs. escitalopram in patients with well treated Major Depressive Disorder...
17 June 2014 | By Novartis
Novartis announced the submission of a Biologic License Application to the US Food and Drug Administration for marketing approval for the use of Bexsero® (Multicomponent Meningococcal Group B Vaccine...
6 June 2014 | By Boehringer Ingelheim
Boehringer Ingelheim announces that Pradaxa® (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism...
5 June 2014 | By The European Medicines Agency
European regulatory authorities have finalised their assessment of reported non-compliance with Good Manufacturing Practice at Ranbaxy Laboratories’ manufacturing site...
4 June 2014 | By Boehringer Ingelheim
Boehringer Ingelheim announced that by a letter dated June 2, the United States Food and Drug Administration has informed the Company about the closure of the Warning Letter...
3 June 2014 | By AstraZeneca
AstraZeneca announced that the US Food and Drug Administration has designated its novel investigational drug AZD0914 as a Qualified Infectious Disease Product...
