EMA announces final steps for its clinical-trial data policy
9 April 2014 | By The European Medicines Agency
Targeted discussions with key stakeholders in May...
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9 April 2014 | By The European Medicines Agency
Targeted discussions with key stakeholders in May...
7 April 2014 | By The European Medicines Agency
In a meeting at the European Medicines Agency on 4 April 2014, the EMA’s Executive Director, Prof. Guido Rasi, and the National Manager of the Australian Therapeutic Goods AdministrationExternal link icon, Prof. John Skerritt, announced that the two regulators have agreed to share the full assessment reports...
1 April 2014 | By Shire
Shire plc announced the acceptance of submission of a Marketing Authorisation Application by the European Medicines Agency for their once-daily, non-stimulant guanfacine extended release...
26 March 2014 | By The European Medicines Agency
Handling of all other evaluation procedures to remain unchanged until further announcement later this year...
26 March 2014 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the European Commission has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan® (albiglutide)...
24 March 2014 | By The European Medicines Agency
Restrictions intended to limit risks of severe diarrhoea and effects on the liver...
24 March 2014 | By The European Medicines Agency
The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the granting of a marketing authorisation for Sylvant (siltuximab)...
24 March 2014 | By The European Medicines Agency
Vynfinit (vintafolide) offers treatment for women with limited therapeutic options; two diagnostic medicines recommended for approval will help identify patients most likely to respond...
24 March 2014 | By The European Medicines Agency
This page provides an overview of the opinions adopted at the March 2014 meeting of the Committee for Medicinal Products for Human Use and other important outcomes...
21 March 2014 | By The European Medicines Agency
Entyvio (vedolizumab) offers a treatment option for patients who do not respond to standard therapies...
19 March 2014 | By The European Medicines Agency
The European Medicines Agency has published its work programme for 2014...
4 March 2014 | By The European Medicines Agency
The European Medicines Agency reminds applicants and marketing-authorisation holders that adjusted fees will be coming into effect on Tuesday 1 April 2014...
28 February 2014 | By Merck
Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of a new, investigational tablet formulation of NOXAFIL®...
25 February 2014 | By The European Medicines Agency
Over the past twelve months, a total of 12 medicines for the treatment of rare diseases were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use...
21 February 2014 | By The European Medicines Agency
The European Medicines Agency has concluded its review of Protelos/Osseor and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis...