FDA’s annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathways.
FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong performance under an integrated inspection and facility evaluation framework.
FDA’s annual report on drug approvals says the majority of novel drugs approved in 2025 moved through accelerated regulatory pathways.
FDA says it continued to improve the speed and consistency of drug manufacturing oversight in fiscal year 2024, citing strong performance under an integrated inspection and facility evaluation framework.
FDA cites Asahi Kasei Finechem Co. for significant quality control deficiencies following a November inspection of the company’s active pharmaceutical ingredient (API) manufacturing facility in Japan.
Advocacy groups urge Congress to advance legislation that would eliminate the statutory distinction between biosimilars and so-called interchangeable biosimilars.
