After a series of regulatory and clinical setbacks for Sanofi’s tolebrutinib, the French pharma has scored a victory for the ...

The EMA has backed broader pediatric use of Agamree and Crysvita, lowering age thresholds for rare genetic diseases affecting muscle and bone development.

A narrow miss in a confirmatory trial has threatened to undo Travere Therapeutics’ accelerated approval in the U.S. for Filspari (sparsentan) as a treatment for IgA nephropathy (IgAN). But that hasn’t ...

Novartis NVS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) ...

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed a fixed-dose combination of aclidinium bromide/formoterol fumarate (340/12 μg) from Almirall as an ...

Amgen Inc. AMGN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended conditional marketing ...

Santhera Pharmaceuticals (SIX: SANN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending ...

If confirmed by the European Commission, REDEMPLO would be the first and only siRNA medicine authorized in the EU for both genetically confirmed and clinically diagnosed adult patients with FCS– ...

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The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars. The CHMP also recommended approval of Biocon’s YESTINTEK ...

Arrowhead on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers Redemplo as an adjunct to diet to reduce tri ...