Accelerated
AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer
AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval
PTC crashes as win for Novartis-partnered Huntington’s drug fails to convince investors
factor IX, PTC518, Accelerated, Approved, United States Food and Drug Administration
FDA chief Makary talks expediting drug approvals, RIFs and the abortion pill
United States Food and Drug Administration, Califf, Unspecified Abortion, Contraceptives, Oral, Accelerated, Artificial Intelligence, RIFs, Infrequent, Agencies
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