NL Times8h
European Medicines Agency ditches Elon Musk’s X in favor of Bluesky
The European Medicines Agency (EMA), which is the regulator for vaccines and medicine in the European Union (EU), has stopped ...
FiercePharma8h
Seeking new social media horizons, EMA joins mass migration from X to Bluesky
As users continue to leave X (formerly Twitter) en masse, many in favor of the newer Bluesky platform, the European Medicines ...
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial; U.S. regulatory approval in WHIM syndrome ...
FDA & EMA Accept Biogen's Filings for Higher Dose SMA Drug
BIIB's regulatory filings are supported by late-stage data, which show that treatment with a higher Spinraza dose improves motor function in infants with SMA.
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Biogen’s higher dose Spinraza under review by US and EU regulators
Biogen’s applications for the higher dose regimen of SMA drug Spinraza are now under review in the US and Europe.