Dr. Marty Makary, Trump's nominee to lead the FDA, said he would review a Biden-era rule that allowed patients to obtain ...

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 ...

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.

Johnson & Johnson's nipocalimab earns FDA Fast Track status for Sjögren's disease, speeding development and review for unmet medical needs.

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

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

Ketamine stock PharmaTher Holdings (CSE:PHRM) has received an amendment acknowledgement letter from the U.S. Food and Drug ...

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 ...

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

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 ...