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March 13, 2020
The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).
EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.
March 06, 2020
European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.
The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.
March 02, 2020
No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.
EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.
February 26, 2020
Kyowa Kirin has announced that its treatment for X-linked hypophosphatemia (XLH), Crysvita (burisumab), has been approved by Swissmedic for use in adults, adolescents, and children (1 year and older).
February 21, 2020
As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.
February 19, 2020
The European Commission (EC) has approved Pfizer’s treatment for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis).
February 18, 2020
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has recommended that the use of cyproterone be restricted as a result of the potential risk of meningioma.