GlobalData on MSN
FDA prevails over EMA in 2025 novel drug approvals
This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...
1don MSN
Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns
The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
In July 2025, a class 2 resubmission of tab-cel’s BLA was initiated by Atara Biotherapeutics, developer and sponsor of ...
In this study, researchers sought to determine the impact of the FDA’s Accelerated Approval pathway among patients with solid tumors.
NRX-100 (preservative-free ketamine) has been granted Fast Track Designation by FDA for treatment of suicidal ideation in ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
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