News

FDA approves label updates for BMS’ CAR T cell therapies
Bristol Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has given approval to label updates ...
CURE2h
FDA Approves CAR T Therapy Label Updates Across Various Blood Cancers
Label updates have been approved by the FDA for the CAR T-cell therapies Breyanzi and Abecma in large B cell lymphoma and ...
PharmExec1h
FDA Approves Label Updates for BMS' Breyanzi, Abecma in Lymphoma, Myeloma
Label changes remove Risk Evaluation and Mitigation Strategy programs and eases monitoring requirements, supporting broader ...
Bristol Myers wins favorable FDA label updates for cell therapies Breyanzi and Abecma
Bristol Myers (BMY) receives FDA approval for label updates for Breyanzi and Abecma, that can ease access to the cancer cell ...
Targeted Oncology3h
FDA Approves Updated Labels on 2 CAR T-Cell Therapies
FDA updates CAR T-cell therapy labels for liso-cel and ide-cel, easing monitoring requirements and expanding access for ...
FDA Eases Rules For Bristol Myers' Cell Therapies For Blood Cancers
FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety ...
FDA Grants Label Expansion to AstraZeneca's Datroway in Lung Cancer
FDA expands AstraZeneca's Datroway label, making it the first TROP2-directed lung cancer therapy approved in the United ...
CURE4d
Illuccix is FDA Approved to Guide Radioligand Use in Prostate Cancer
FDA approved to help select patients with metastatic prostate cancer for radioligand therapy before chemotherapy.
MPR2h
FDA Removes REMS, Reduces Monitoring Requirements For Breyanzi and Abecma
The Breyanzi REMS program and the Abecma REMS program were established due to the risk of cytokine release syndrome and neurologic toxicities.
PharmExec1d
FDA Expands Eli Lilly’s Amyvid Label to Guide Alzheimer Treatment Decisions
The label update for Amyvid adds guidance for assessing amyloid plaque levels and may help inform diagnostic and treatment ...
Healio23h
FDA approves its requested updated warning labels for COVID-19 vaccines
The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously ...
Becker's Hospital Review3h
FDA expands approval of imaging agent to aid Alzheimer’s diagnosis
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 ...