The application was supported by positive results from two global Phase III studies in people with cystic fibrosis aged 12 and older.
List view / Grid view
European Medicines Agency (EMA)
Filter the results
A new liquid formulation of hydroxycarbamide to treat sickle cell disease will “enable doctors to personalise doses in children".
The pharmaceutical company Sanofi is voluntarily recalling its OTC Zantac products in the US and Canada due possible contamination with NDMA.
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
A Biologics License Application and priority review has been approved by the FDA for an investigational Ebola vaccine.
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
The Kymriah (tisagenlecleucel) treatment has received a positive appraisal from the Scottish Medicines Consortium, after EMA approval last year.
The EMA will assess the marketing authorisation for the medication to see whether it is a cause of skin cancer in patients.
The Chinese pharmaceutical industry has been lagging behind in terms of drug development and bringing new products to the market. In this article, Megha Baruah discusses the changes the National Medical Products Administration (NMPA) of China is making to existing policies and informs on guidance documents that have been released…