The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

EMA establishes regular procedure for scientific advice on certain high-risk medical devices: Amsterdam, The Netherlands Wednesday, February 12, 2025, 13:00 Hrs [IST] EMA, in clos ...

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...

The NZD/USD pair is testing a critical support level at 0.5650. A decisive break below this level could push the pair toward ...

EUR/JPY soars to near 159.60 amid a notable weakness in the Japanese Yen. BoJ Ueda warned that food prices could rise and ...

Operator Good afternoon, everyone, and welcome to Gilead's fourth quarter and full year 2024 earnings conference call. My ...

1 Christoffersen M et al. Transthyretin Tetramer Destabilization and Increased Mortality in the General Population. JAMA ...

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 ...

Telethon Foundation is seeking approval for a gene therapy to treat the rare disease Wiskott-Aldrich syndrome.

Bayer seeks European approval of extended 6-month treatment interval for Eylea 8 mg to treat nAMD & diabetic macular edema: Berlin Tuesday, February 11, 2025, 10:00 Hrs [IST] Baye ...

The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2506 as a biosimilar to reference p ...

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...