You are here: Industry Insights > EMA

News List

EMA stops imports of sterile drugs from Lampugnani Farmaceutici plant fiercepharma
July 26, 2018
European regulators are taking quick action against an Italian CDMO after they found what they called major deficiencies in its production of sterile drugs.
U.K. votes to ‘fully participate’ in EMA after Brexit biospectrumasia
July 23, 2018
British politicians have voted for the U.K. to try to remain close to the EMA after Brexit.
EMA issues global recall of heart drugs over cancer risk contamination pharmafile
July 17, 2018
Several drugs designed for the treatment of high blood pressure and heart conditions have been recalled across Europe over fears they could contain a probable carcinogen and thus pose an increased risk of cancer in users, it has emerged.
EMA survey identifies gaps in pharma industry's preparedness for Brexit pharmafile
July 17, 2018
An EMA survey has identified gaps in the pharmaceutical industry’s preparedness for Brexit, finding that only 58% of market authorisation holders are on track with their regulatory planning in preparation for the UK’s exit from the European Union in March
Europe recalling some valsartan meds on safety fears pharmatimes
July 09, 2018
The European Medicines Agency is reviewing medicines containing valsartan supplied by a facility in China after a potentially cancer-causing impurity was detected.
EMA approves Cimzia for use in treating plaque psoriasis pharmafile
July 06, 2018
The Brussels-based pharmaceutical company UCB has announced that the European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol), to include a new indication in adult patients with moderate-to-severe plaque psoriasis.
FDA and EMA accept marketing application for Pfizer’s talazoparib pharmaceutical-technology
June 13, 2018
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted Pfizer’s marketing authorisation application for its talazoparib drug to treat metastatic breast cancer patients with an inherited BRCA mutation.
EMA recommends marketing authorisation to Tegsedi for hereditary transthyretin amyloidosis biospectrumasia
June 08, 2018
The EMA has recommended granting a marketing authorisation for Tegsedi, a medicine for the treatment of stage 1 or stage 2 polyneuropathy…
EMA review confirms risks of Abbvie and Biogen's Zinbryta outweigh benefits pharmafile
May 25, 2018
The EMA has judged that the benefits offered by Zinbryta (daclizumab), Abbvie and Biogen’s humanised IgG1 monoclonal antibody for the treatment of multiple sclerosis (MS), do not outweigh its risks, following a review carried out by the agency’s Pharmacov
EMA confirms risks of MS drug Zinbryta pharmatimes
May 24, 2018
The Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that Zinbryta (daclizumab) “poses a risk of serious and potentially fatal immune reactions affecting the brain, liver and other organs.”

Previous page 1 2 3 4 5 6 7 8 9 10 ... 31 32 Next page