The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...

The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...

The U.S. Food and Drug Administration said on Monday it is revising the labeling of all extended-release stimulants used to ...

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, easing monitoring requirements and expanding access for eligible patients in oncology.

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

The Food and Drug Administration (FDA) has approved an updated label for Amyvid (florbetapir F 18 injection) to support Alzheimer disease diagnosis in patients.

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

Merck's Winrevair gains FDA priority review for PAH label update after ZENITH trial shows major reduction in serious events and strong clinical impact.

Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants.

In 2019, the FDA approved Mavyret to shorten the once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients across all ...

FDA approves AbbVie's Mavyret for acute hepatitis C, expanding its use to patients 3 and older with or without cirrhosis after positive trial data.