The process of discovering new drugs and bringing them to market is notoriously slow and inefficient. Amazon Web Services is hoping to use AI to streamline this process, it announced Tuesday. Amazon ...
Let’s start this story with a sing-along to the tune of “My Favorite Things.” Foundayo, Mounjaro, Zepbound and Ozempic. Skyrizi, Wegovy, Rinvoq and Dupixent. Tremfya, Jardiance, Nurtec ODT. These are ...
A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Illustration of New Drug Application paperwork surrounded by pills, vials, and DNA. The US Food and Drug Administration approved 46 new molecular entities in 2025. Credit: C&EN/Shutterstock The year ...
In a new draft guidance document, “New Clinical Investigation Exclusivity (3‑Year Exclusivity) for Drug Products: Questions and Answers,” FDA is stepping in to help drug sponsors prepare a request for ...
In July 2025, the US Food and Drug Administration (FDA) announced a pilot program intended to expedite reviews for drug applications that met one of five national priorities, including products deemed ...
NDA submission based on the Phase 2b REZILIENT1 clinical trial, which demonstrated clinically meaningful and durable responses in patients with relapsed EGFR exon 20 insertion–mutated NSCLC ...
In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of ...
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