You are here: Industry Insights > EMA

News List

EMA to provide guidance on avoiding nitrosamines in medicines europeanpharmaceuticalreview
September 18, 2019
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
NDMA discovered in samples of ranitidine medicines europeanpharmaceuticalreview
September 17, 2019
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
EMA to review Picato after rise in skin cancer cases europeanpharmaceuticalreview
September 09, 2019
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
Viralgen Receives EMA cGMP Certification contractpharma
September 06, 2019
Spanish contract development and manufacturing organization (CDMO) Viralgen, a joint venture between AskBio and Columbus Venture Partners, has received current Good Manufacturing Practices (cGMP)...
Licence extension submission accepted for kidney disease treatment by EMA europeanpharmaceuticalreview
August 29, 2019
The licence extension submission for Invokana and Vokanamet has been accepted by the EMA.
FDA and EMA align on 90 percent of marketing authorisation decisions europeanpharmaceuticalreview
August 23, 2019
A study has found that between 2014 and 2016, the EMA and FDA had very little divergence in their marketing authorisation decisions.
EMA Validates Marketing Application for Filgotinib for Rheumatoid Arthritis americanpharmaceuticalreview
August 19, 2019
Gilead Sciences and Galapagos announced that the Marketing Authorization Application (MAA) for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of adults with rheumatoid arthritis (RA) has been validated and ...
Liposomal medicine names to be changed to avoid errors europeanpharmaceuticalreview
August 07, 2019
The EMA has requested that liposomal medication names be changed to avoid the risk of confusion.
EMA recommends Vitrakvi for EU marketing authorisation europeanpharmaceuticalreview
July 30, 2019
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
EMA grants AR-501 with Orphan Drug Designation europeanpharmaceuticalreview
July 23, 2019
Orphan Drug Designation has been given to AR-501 for the treatment of lung infection in patients with cystic fibrosis.

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