CHMP
Feb 27, 2024
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease; GSK Announces Positive Headline Results from EAGLE-1 Phase III Trial; Dupixent sBLA Accepted for FDA Priority Review; Biogen’s QALSODY Received Positive Opinion from CHMP; FDA Granted Orphan Drug Designation to Immune-Onc’s IO-202; Artiva Biotherapeutics’s AlloNK® in Lupus Nephritis
Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease due to MASH, with Significant Improvements in Fibrosis Boehringer Ingelheim has reported that in a Phase II trial, a significant proportion of adults treated with survodutide (BI 456906), up to 83.0%, showed a notable enhancement in metabol...
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Dec 19, 2023
Eisai Submits Marketing Authorization Application for Tasurgratinib; CHMP Issues Positive Opinion for Biogen’s SKYCLARYS; European Commission Approves Merck’s KEYTRUDA + Chemotherapy HER2-ve Gastric or GEJ Adenocarcinoma; BMS Provides Update on RELATIVITY-123 Trial; Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101; Verrica and Torii Pharma Announces Positive Top-line Results from a Confirmatory Phase 3 Trial of TO-208
Eisai Submits Marketing Authorization Application In Japan for Anticancer Agent Tasurgratinib For Biliary Tract Cancer With FGFR2 Gene Fusion Eisai Co., Ltd. has officially submitted a request for marketing authorization in Japan for tasurgratinib succinate, its internally developed tyrosine kinase inhibitor tar...
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Nov 14, 2023
Takeda’s ADZYNMA Approved by FDA; AskBio Presents Preliminary Data from Phase I Trial of Gene Therapy for CHF; Bayer’s Aflibercept 8 mg Recommended for Approval in EU; FDA Orphan Drug Designation to MAIA Biotechnology’s THIO; First Patient Dosed in Phase III ProstACT GLOBAL Study; FDA Grants Orphan Designation for Lipella’s LP-310 Drug Candidate
Takeda’s ADZYNMA Approved by FDA as the First and Only Recombinant ADAMTS13 Enzyme Replacement Therapy for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura Takeda has received FDA approval for ADZYNMA (ADAMTS13, recombinant-krhn) for both prophylactic and on-demand treatment in adults and pediatri...
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May 09, 2023
FDA Approves GSK’s Arexvy for RSV; CHMP’s Opinion on Gilead’s Hepcludex® for HDV; FDA Clearance to ProMIS’s IND Application for PMN310; FDA Grants 501K Clearance to Bladder EpiCheck; PharmaTher Submits Fast Track Application for Ketarx to US FDA; Fast Track Designation to Vedanta Biosciences’ VE303
FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...
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