Metastatic Urothelial Carcinoma
Aug 27, 2024
Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer
Merck’s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR™ (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU me...
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Apr 04, 2023
HUTCHMED’s NDA Submission to FDA for Fruquintinib; Cytokinetics to Discontinue ALS Drug Candidate Following Phase III Trial Failure; Enfortumab Vedotin + Pembrolizumab Approved for Urothelial Carcinoma; Nanoscope Gene Therapy Clears Phase II Retinitis Pigmentosa Trial; FDA Clearance to Cabaletta Bio’s IND Application for CABA-201 for SLE Treatment; European Orphan Drug Designation to Gene Therapy Candidate DB-OTO
HUTCHMED Completes Rolling Submission of NDA to FDA for Fruquintinib HUTCHMED (China) Limited announced the completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1,...
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