Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...

Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader ...

Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...

FDA updates CAR T-cell therapy labels for liso-cel and ide-cel, easing monitoring requirements and expanding access for ...

FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...

The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...

The FDA has approved expanded use of GE HealthCare’s PET imaging agent, Vizamyl, for improved detection and monitoring of Alzheimer’s disease. The updated label now allows Vizamyl to be used to detect ...

The American Academy of Neurology issues new guidelines to help clinicians navigate the use of unproven neurologic therapies lacking FDA approval or strong evidence.

Vizamyl is now additionally indicated for use in a selection of patients who are indicated for amyloid beta-directed therapy as described in the prescribing information.

A new study reveals just how widespread these artificial colorings have become in our food supply. Nearly one in five ...

The company has already secured approval for Fintepla in treating Dravet syndrome and Lennox-Gastaut syndrome.