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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 ...
A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...
Below is a review of novel drug and biological products approved by the Food and Drug Administration (FDA) in 2025. The list ...
On August 8, 2025, the FDA granted accelerated approval to zongertinib for adult patients with unresectable or metastatic nonsquamous NSCLC harboring HER2 (ERBB2) tyrosine kinase domain (TKD) ...
An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
Two obesity drugs are among the six new medications that could get faster FDA review under a new pilot program open to products addressing certain national health priorities. Rare and infectious ...
Commissioner Makary has directed all FDA centers to begin deployment of AI-assisted scientific review, with the goal of a complete roll-out by June 30, 2025. The announcement notes that FDA will ...
How the new health secretary, Robert F. Kennedy Jr., is dismantling the agency. Credit...Animation By Aimee Sy Supported by By Jeneen Interlandi Jeneen Interlandi, a domestic correspondent for Opinion ...
The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday. The voucher was granted to J&J for ...
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