The process of discovering new drugs and bringing them to market is notoriously slow and inefficient. Amazon Web Services is ...
The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...
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 ...
Please provide your email address to receive an email when new articles are posted on . The single inhaler includes an inhaled corticosteroid, a long-acting beta-agonist and an anticholinergic. The ...
Daraxonrasib, a new pancreatic cancer drug, cut the risk of death by 60% in a Phase 3 trial. A doctor explains how it works, ...
The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
Zanzalintinib plus Tecentriq showed improved survival in metastatic colorectal cancer patients compared to Stivarga in the STELLAR-303 trial. The FDA accepted the new drug application for this ...
Determination of bioequivalence to the Reference Listed Drug is essential for approval of an Abbreviated New Drug Application (ANDA). FDA has advised NRx in written correspondence that it has not ...
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