PipelineReview.com23h
Ipsen’s Iqirvo® (elafibranor) approved in the European Union as first new treatment for primary biliary cholangitis in nearly a decade
PARIS, France I, 2024 I Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the European Commission has conditionally approved Iqirvo® ...
PipelineReview.com23h
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
NEW YORK, NY, USA & MAINZ, Germany I, 2024 I Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced ...
PipelineReview.com23h
CD (Suzhou) Biopharma Announces FDA Clearance for Phase I Clinical Trial of CD-001
Biopharma has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of CD-001, entering a Phase I first-in-human trial. CD-001, the ...
PipelineReview.com21h
FDA Approves First Treatment for Niemann-Pick Disease, Type C
SILVER SPRING, MD, USA I September 20, 2024 I Today, the U.S. Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Niemann-Pick disease, type C (NPC).
PipelineReview.com23h
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™
INCHEON, South Korea and CAMBRIDGE, MA, USA I September 20, 2024 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European ...