Myeloma BCMA Therapy In Spotlight: EMA Considers Fast Tracking GSK Filing
EU Filing Understood To Be Expected in H1 2020
The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.
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Bristol-Myers Squibb’s newly acquired company Celgene is one of two drug sponsors that this month made it onto the European Medicines Agency’s priority medicines scheme. The other is Achillion Pharmaceuticals, which is developing a treatment for paroxysmal nocturnal hemoglobinuria.
Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.
ViiV Healthcare has asked the European Medicines Agency to accelerate its review of fostemsavir when the company files for pan-EU market approval of the product.