FDA Chief Robert Califf reflects on potential changes as Trump's re-election looms, expressing disappointment and ...
The FDA has a public portal where patients or caregivers can report new drug shortages, opens new tab. It also tracks existing or known drug shortages on its website.
The FDA in 2016 granted accelerated approval to the FXR agonist as a second-line treatment for adults with PBC, either in ...
The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...
The FDA officially deemed the nearly two-year shortage ... Welch logged into his wholesaler portal and was surprised to see "zero allocation" for Mounjaro and Zepbound, meaning he was still ...
The FDA has approved an ingestible event marker ... a secure smartphone app and healthcare provider in a secure web-based portal. Proteus has developed a similar system, except its reader is ...
Scemblix (asciminib) is a new first-line option for adults with newly diagnosed Philadelphia chromosome-positive chronic ...
Recently the U.S. Food and Drug Administration (FDA) issued updated safety warnings for all glucagon-like peptide 1 receptor ...
Kennedy Jr., who is slated to hold a potentially big role in a new Trump administration, said Wednesday there are “entire departments” within the Food and Drug Administration (FDA) that ...
As AI technology evolves rapidly, the FDA is tackling the challenge of balancing innovation with patient safety, shaping regulations that ensure AI tools remain effective throughout their entire ...
The Food and Drug Administration (FDA) has expanded a recall of Dynacare-brand baby powder, manufactured by the Dynarex Corporation, due to potential asbestos contamination. Recent tests have ...
The FDA were even more intrigued when they learned that Homeland Security was also after Fadanelli after Customs and Border Patrol allegedly seized packages addressed to her that contained illegal ...