Accelerated
NVIDIA’s AI Innovations: Pioneering the Future of Artificial Intelligence
NVIDIA AI Innovations, Generative AI, Accelerated Computing, Robotics, AI in Healthcare, AI Foundation Models
2024 FDA Drug Approvals: A Year of Strategic Approvals and Long-Awaited Treatments
FDA drug approvals 2024, novel drug approvals, accelerated approvals, cancer treatments, rare disease therapies
uniQure Secures FDA Agreement on Accelerated Approval Pathway for Huntington’s Disease Gene Therapy AMT-130
uniQure, FDA, Accelerated Approval, Huntington’s Disease, Gene Therapy, AMT-130, cUHDRS, Neurofilament Light Chain (NfL), Regenerative Medicine Advanced Therapy (RMAT)
FDA Grants Accelerated Approval to Merus’ Bizengri for NRG1+ Lung and Pancreatic Cancers
Bizengri, NRG1+ cancers, FDA accelerated approval, lung cancer, pancreatic cancer, zenocutuzumab-zbco, Merus N.V.
FDA Denies Full Approval for Ocaliva in Primary Biliary Cholangitis, Accelerated Approval Stands
FDA, Ocaliva, Intercept Pharmaceuticals, primary biliary cholangitis, accelerated approval, rare liver disease
Gilead Withdraws US Indication for Sacituzumab Govitecan in Metastatic Urothelial Cancer
Sacituzumab Govitecan, Trodelvy, Bladder Cancer, Urothelial Cancer, Gilead Sciences, FDA, Accelerated Approval Withdrawal
Sangamo Therapeutics Aligns with FDA on Accelerated Approval Pathway for ST-920 Gene Therapy in Fabry Disease
Sangamo Therapeutics, FDA, Accelerated Approval Pathway, ST-920, Fabry Disease, Gene Therapy, BLA Submission
Sangamo Therapeutics Fast-Tracks Fabry Gene Therapy with FDA Accelerated Approval Pathway
Sangamo Therapeutics, Fabry disease, gene therapy, isaralgagene civaparvovec, FDA, accelerated approval pathway, ST-920, STAAR study
Otsuka Seeks Accelerated Approval for Sibeprenlimab in IgA Nephropathy Following Positive Phase III Interim Results
Otsuka, sibeprenlimab, IgA nephropathy, Phase III trial, accelerated approval, FDA, kidney disease, autoimmune disease, APRIL antibody.
Gilead Withdraws Trodelvy for Bladder Cancer in US After Confirmatory Trial Failure
Gilead Sciences, Trodelvy, bladder cancer, urothelial carcinoma, FDA, accelerated approval, drug withdrawal