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While there's little disagreement that speeding drug approvals would be a good thing, there are more questions than answers ...
Phase 1/2a clinical trial currently supported by a $3.0 million grant from the U.S. Department of Defense Trial will enroll ...
Revuforj is designed to treat patients with relapsed or refractory mutant NPM1 acute myeloid leukemia. The application has been assigned a real-time oncology review, which allows for a more efficient ...
Mumbai: Global pharma major Lupin Limited has launched Prucalopride Tablets, 1 mg, and 2 mg, in the United States, following ...
Aldeyra had received 2 complete response letters (CRL) from the FDA in April 2025 and November 2023 for past submissions.
The U.S. FDA is launching a program under which its commissioner can issue vouchers to companies he finds are aligned with ...
The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...
The program will bring together experts from across the FDA for a team-based review, rather than having an application move ...
In a Phase I/II clinical trial, TKI-pretreated NSCLC patients given zidesamtinib had an overall response rate of 44 percent.
Novo Nordisk NOVO.B0.48%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...
NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with ...
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