The FDA approved an expanded label for Iluvien, which is now indicated for the treatment of chronic noninfectious uveitis ...

Based on the TRAVERSE trial results, the FDA has recommended that the Boxed Warning related to an increased risk of adverse cardiovascular outcomes be removed from the labels of testosterone products.

The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on ...

The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo ...

Having a tough time reading those food labels? And what constitutes healthy, and can you believe what manufacturers say on a package? The U.S. Food and Drug Administration is trying to help.

Lipocine (LPCN) announced that the FDA has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency’s review of the ...

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, seafood, poultry, meat and dairy (excluding plant-based ...

Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with ...

Indivior PLC, a global leader in addiction treatment, announced that the US Food and Drug Administration (FDA) has approved label changes for Sublocade including a rapid initiation protocol and ...

An off-label prescription drug has been shown to help some non-verbal children with autism discover the ability to speak. The drug, leucovorin, is a prescription vitamin that functions similarly ...

Rapid initiation Protocol: Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability.