AstraZeneca's Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult patients with early-stage (IB, II.
Disclaimer: Intended for international media and investor audiences only Ipsen confirms U.S. FDA accepts New Drug Application for palovarotene as the first potential treatment worldwide for fibrodysplasia ossificans progressiva (FOP) New Drug Application granted Priority Review status, with a decision anticipated on 30 November 2021 Authorization Application (MAA) for palovarotene with Swissmedic granting palovarotene a priority review PARIS, FRANCE, 28 May 2021 - Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP), has been accepted by the U.S. Food and Drug Administration (FDA). The target regu
New Drug Application granted Priority Review status, with a decision anticipated on 30 November 2021 European Medicines Agency (EMA) and Swissmedic have also validated the Marketing Authorization
GSK - GlaxoSmithKline plc (via Public) / GSK and Vir Biotechnology announce sotrovimab (VIR-7831) receives Emergency Use Authorization from the US FDA for treatment of mild-to-moderate COVID-19 in high-risk adults and paediatric patients publicnow.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from publicnow.com Daily Mail and Mail on Sunday newspapers.
MELBOURNE, Australia and SOUTHAMPTON, United Kingdom, May 25, 2021 (GLOBE NEWSWIRE) Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today .