The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
In a Q&A, an FDA spokesperson discusses efforts to reduce misinformation about biosimilars through education, the agency’s collaboration with global regulators to streamline development, and its work ...
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...
In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a new initiative to significantly reduce, refine, and replace animal testing ...
TARA-002 selected for FDA manufacturing development and readiness pilot programNEW YORK, Jan. 05, 2026 (GLOBE NEWSWIRE) -- ...
Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...
AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United StatesTherapy granted United States Food ...
Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...
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