PharmiWeb7h
Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted conditional marketing authorization for seladelpar for the treatment of primary biliary cholangitis ...
News Medical1d
The Latest Advances in Cell and Gene Therapy
The evolution of cell and gene therapy is reshaping drug discovery, providing new hope for rare diseases and cancer through innovative gene editing approaches.
Apellis announces EMA validation of Aspaveli indication extension application
Apellis (APLS) and Sobi announced the European Medicines Agency has validated an indication extension application for Aspaveli for the ...
News Medical2d
Tampere University licenses drug for Epidermolysis Bullosa to Theravia
Tampere University has licensed a drug molecule intended for treating Epidermolysis Bullosa (EB), a group of rare and severe skin disorders, to Theravia, a pharmaceutical company headquartered in the ...
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...
PharmiWeb2d
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for lenacapavir—the company’s twice-yearly ...
consilium.europa5d
EU health policy
The EU regulates the authorisation of medicines at EU level by the European Medicines Agency or at national level by the competent authorities in EU countries. Special rules exist for the ...