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A Health Affairs analysis on FDAs new pathway allowing drug approvals based on a plausible mechanism of action warns that the appr...[ Price : $8.95]
Sarepta Therapeutics announces that its gene therapy Elevidys significantly slowed disease progression over three years in ambulat...[ Price : $8.95]
AMT-130 is a gene therapy designed to lower levels of the mutant huntingtin protein believed to drive Huntingtons disease progress...[ Price : $8.95]
U.S., U.K. and Canadian drug regulators announce a joint international symposium to discuss evolving regulatory expectations for c...[ Price : $8.95]
Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-cal...[ Price : $8.95]
Sanofi says its experimental antibody amlitelimab showed consistent efficacy and a favorable safety profile across multiple late-s...[ Price : $8.95]
FDA approves Guardant Healths Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600Emutant m...[ Price : $8.95]
FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong perf...