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3 November 2014 | By Birken
Birken AG, a biopharmaceutical and dermo-cosmetic company, announces that the European Medicines Agency has accepted its Oleogel-S10 Marketing Authorization Application for review...
27 October 2014 | By The Institute of Cancer Research
The European Medicines Agency has approved olaparib for women with ovarian cancer who have a BRCA mutation - the first time a cancer drug has been approved targeted at an inherited genetic fault...
27 October 2014 | By Clinuvel Pharmaceuticals Limited
The first new pharmaceutical drug invented and developed for an untreated disorder by any Australian company has received regulatory approval from the European Medicines Agency (EMA). SCENESSE® (afamelanotide 16mg) treats the debilitating genetic disorder porphyria (EPP), or absolute intolerance to sunlight...
24 October 2014 | By European Medicines Agency
Rapid scientific advice to speed up development...
21 October 2014 | By The European Medicines Agency
EMA encourages companies to apply for orphan designation...
29 September 2014 | By Janssen
Janssen-Cilag International NV announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a Positive Opinion recommending REZOLSTA™...
29 September 2014 | By Gilead
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company’s Marketing Authorization Application for Harvoni®...
26 September 2014 | By Almirall S.A
Almirall S.A. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion for the regulatory approval of Duaklir® Genuair® (aclidinium bromide/formoterol fumarate) in all EU member states...
17 September 2014 | By AstraZeneca
AstraZeneca announced that the US Food and Drug Administration approved MOVANTIK™ (naloxegol) tablets C-II as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain...
3 September 2014 | By European Medicines Agency
The European Medicines Agency is pleased to announce two new appointments to its management team...
3 September 2014 | By Amgen
First Marketing Authorization Application for an oncolytic immunotherapy in the European Union...
11 August 2014 | By Boehringer Ingelheim
The research-driven pharmaceutical company Boehringer Ingelheim overcame major challenges in the first half of 2014...
8 August 2014 | By Pfizer
Application includes data from Pfizer’s community-acquired pneumonia immunization trial in adults (CAPiTA)...
7 August 2014 | By The European Medicines Agency
European system to be used as model to facilitate assessment of medicines...
4 August 2014 | By The European Medicines Agency
The European Medicines Agency has released a draft concept paper for public consultation outlining the key elements that will be developed in a guideline on good genomics biomarker practices...
