Dr. Tycel Phillips discusses the FDA approval of a Calquence combo in MCL, making it the first and only BTK inhibitor ...

The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...

The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease ...

The ad goes on to tout Hims & Hers' weight loss drugs as less expensive alternatives to medications like Ozempic and Wegovy, ...

For the first time in 20 years, the Food and Drug Administration has approved a new pharmaceutical approach to treating pain.

The FDA indicated something was not well with Provention Bio's filing for type 1 diabetes therapy teplizumab in April when it delayed its review. Now, the agency has rejected the application ...

GOMEKLI™ is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric ...

For the first time in decades, a new class of painkiller has been approved by the US Food and Drug Administration (FDA).

Canned tuna sold at Trader Joe's, Costco, and H-E-B recalled because they may be contaminated with bacteria that causes ...

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