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FDA cites Pine Pharmaceuticals for multiple quality and sterility violations following a 10-day inspection of the companys drug ou...[ Price : $8.95]
FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong perf...[ Price : $8.95]
FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the companys ac...[ Price : $8.95]
FDAs annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathwa...[ 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]
Six King & Spalding attorneys analyze FDA advertising and promotion enforcement letters for drugs and medical devices issued in 20...