Incyte’s ruxolitinib franchise, made up of blockbuster JAK inhibitor Jakafi and its topical counterpart Opzelura, have been ...

FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...

Be cautious with your favorite pastries this week.

Public health experts worry the FDA workforce will be slashed, impeding the ability of the agency to review new medicines ...

Despite the recent launch of congenital adrenal hyperplasia (CAH) drug Crenessity, Neurocrine Biosciences' disappointing ...

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on delivering therapeutics through effective oral delivery, announced today that it has received revised regulatory guidance for LPCN ...

Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...

Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...

The U.S. Food and Drug Administration (FDA) issued a final guidance for industry titled Action Levels for Lead in Processed Food Intended for ...

Please provide your email address to receive an email when new articles are posted on . FDA issued guidance on decentralized elements of clinical trials last fall. Investigators need to balance ...

Dr. Jane Sykes, a professor of small animal internal medicine at the University of California, Davis, School of Veterinary Medicine, said the FDA guidance lacks important details, including how to ...

Dr. Jane Sykes, a professor of small animal internal medicine at the University of California, Davis, School of Veterinary Medicine, said the FDA guidance lacks important details, including how to ...