Bayer AG BAYRY recently announced that the FDA had accepted its supplemental new drug application (sNDA) seeking approval for ...

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

While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to ...

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.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for finerenone for the treatment of ...

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 ...

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

FDA nominee Martin Makary was asked about abortion drugs, vaccine panels during a Senate hearing on his bid to lead the ...

The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the ...

In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations.

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 ...

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 ...