The European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) submitted by Soleno ...

Tevimbra is currently approved in the EU as a treatment for gastric cancer, esophageal squamous cell cancer and small cell ...

AstraZeneca (AZN) stock in focus as its antibody drug Imfinzi gains EU panel support for treating muscle-invasive bladder ...

Autolus' CAR-T cell therapy for a rare and aggressive form of acute lymphoblastic leukaemia (ALL), Aucatzyl, has been ...

EMA grants conditional marketing authorization to Autolus’ Aucatzyl to treat adults with acute lymphoblastic leukaemia: Amsterdam, The Netherlands Monday, May 26, 2025, 16:00 Hr ...

Since the European Medicines Agency (EMA) approval of omalizumab in 2005 as the first ever biologic for severe asthma, the ...

USD/JPY struggles to break above the 20-day Exponential Moving Average (EMA), which is currently around 144.45, indicating ...

Industry stakeholders have urged the European Medicines Agency to sharpen its guidance on decentralized clinical trials, ...

EMA committee recommends marketing approval for SpringWorks’ mirdametinib to treat adult & paediatric patients with NF1-PN: Stamford, Connecticut Tuesday, May 27, 2025, 12:00 Hr ...

Discover the key biotech trends moving the industry forward in Europe at a time when there lies uncertainty in global ...

Bitcoin holds above $100K despite ETF outflows and trade tensions. Will fresh macro drivers revive momentum or deepen the ...

In looking across the past four years of regulatory decisions, we noticed that some of the analyses involving the European Medicines Agency (EMA)'s cycle time used an inappropriate endpoint ...