See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks. Biologics License Applications and Supplements New BLAs (except those for blood banking), and ...
See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks. Biologics License Applications and Supplements New BLAs (except those for blood banking), and ...
The FDA approved AstraZeneca’s Lynparza (olaparib) with abiraterone and prednisone (or prednisolone) for adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test. (May 2023...
· 1 min read · Kate Goodwin Neurodegenerative disease UniQure Clears Path to Accelerated Approval for Huntington’s Gene Therapy December 10, 2024 · 2 min read · Tristan Manalac Regulatory FDA Action Alert: Ionis, Lexicon, Bristol Myers Squibb and More ...
The goal of this study was to elucidate if mitochondrial biogenesis (MB) induction with a new, selective and FDA-approved 5-hydroxytryptamine receptor 1F (5-HT 1F ) receptor agonist, lasmiditan, can stimulate locomotor recovery and restoration of the blood-spinal cord barrier (BSCB) after SCI...
See the Development & Approval Process page for a description of what products are approved as Biologics License Applications (BLAs), Premarket Approvals (PMAs), New Drug Applications (NDAs) or 510Ks. Biologics License Applications and Supplements...