Merck gets approval in Europe to extend Kuvan use for children with PKU
The authorization follows the positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in May this year, which was based on a review of
Axsome Therapeutics has received the US Food and Drug Administration (FDA) approval for Auvelity (dextromethorphan HBr and bupropion HCl) to treat agitation associated with dementia due to Alzheimer’s.
The Phase 1/2 results were previously announced in November 2014. Yotam Nisemblat, BioLineRx Drug Development Director, will present the data in a talk titled BL-7010, a Novel Potential