Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment ...

The Food and Drug Administration (FDA) announced a new initiative Tuesday titled “Operation Stork Speed” aimed at reviewing ...

Health and Human Services Secretary Robert F. Kennedy, Jr., has turned his attention to infant formula, with the goal of ...

Bayer has won U.S. Food and Drug Administration priority review for its application seeking expanded approval of its kidney-disease drug Kerendia in certain people with heart failure.

This initiative builds on the agency’s January announcement to “enhance” oversight of infant-formula production as part of a ...

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with ...

The future of American drug innovation is threatened by US regulations that permit knockoff versions of new drugs to be sold to US consumers.

The U.S. Food and Drug Administration will step up its testing for heavy metals in infant formula and review nutrients ...

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for depemokimab for asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps ...

The US Food and Drug Administration (FDA) accepted and granted Priority Review designation for Bayer’s (BAYN: DE) supplemental new drug application (sNDA) for a new indication for Kerendia (finerenone ...

Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for ...