Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates ...

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

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 ...

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 ...

FDA expands AstraZeneca's Datroway label, making it the first TROP2-directed lung cancer therapy approved in the United ...

FDA approved to help select patients with metastatic prostate cancer for radioligand therapy before chemotherapy.

The label update for Amyvid adds guidance for assessing amyloid plaque levels and may help inform diagnostic and treatment ...

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 ...