Withdrawn Oncology /Hematologic Malignancies Accelerated Approvals
Trodelvy (sacituzumab govitecan-hziy)Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1...The Big One: How We Must Prepare for Future Deadly Pandemics
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Michael Osterholm, Mark Olshaker Little, Brown Spark; New York, New York, USA, 2025 ISBN-13:...Video and Transcript
TranscriptThe journey to develop and market a human drug can be long, complex, and filled with regulations.But, FDA’s CDER Small Business and Industry Assistance – or SBIA- is here to help! SBIA provides education, And answersTo help ALL regulated pharmaceutical...Retrospective Phylogenetic Analysis of Mayaro Virus, French Guiana, 1996–2024
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Institut Pasteur de la Guyane, Arbovirus National Reference Center,...VRBPAC Meeting May 28, 2026 Announcement
On This Page Date: May 28, 2026 Time: 8:30 a.m. – 4:30 p.m. ET What is an advisory committee? Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the...All Drug Purchases Are
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