The US Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Beacon ...

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indicati ...

Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started ...

Mark Genovese: Crohn’s disease is a chronic, inflammatory bowel disease associated with progressive bowel damage, disability, ...

GSK (GSK) stock in focus as its experimental drug depemokimab undergoes EU review for asthma and nasal polyps. Read more here ...

ImmunityBio (IBRX) announced the European Medicines Agency has accepted for review and begun assessing the marketing authorization application ...

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the regulatory application of a prefilled syringe ...

The European Medicines Agency (EMA) has decided to stop using the social media platform X due to content concerns and will instead use Bluesky. This move aligns with other organizations stepping back ...

The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...

LONDON - GlaxoSmithKline PLC (LSE/NYSE: NYSE:GSK) announced today that the European Medicines Agency (EMA) has begun ...

Regulators in the U.S. and the European Union agreed to review Biogen’s applications for approval of a higher dose Spinraza ...