New EU Approvals
Executive Summary
The Pink Sheet’s list of EU centralized approvals of new active substances now includes five new products, one of which is BioMarin Pharmaceutical's Palynziq for treating phenylketonuria. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
You may also be interested in...
What Else Analysts Want To Know About Phase III Data For TMC’s Inclisiran
Looking to be a game-changer with a highly effective LDL-C-lowering agent dosed twice annually, The Medicines Company says inclisiran met efficacy endpoints in a large Phase III study. But observers await fuller data, including safety details.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Outlook Turns To Marketing Strategy After Scoring EU First For Ophthalmic Bevacizumab
Outlook Therapeutics’ intravitreally injected Lytenava has won the thumbs up from the European Medicines Agency. The company is assessing both direct commercialization of the product and partnering in Europe on a country-by-country basis.