News

BioSpace1h
Lilly Gets FDA Label Update for Alzheimer’s Drug To Mitigate Safety Concerns
The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...
US FDA approves gradual dosing for Lilly Alzheimer's drug
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 ...
Fierce Pharma23h
Regulatory tracker: With FDA filing, J&J targets Caplyta expansion into schizophrenia relapse prevention
Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...
MPR19h
FDA Approves Oral Ekterly for On-Demand Hereditary Angioedema Treatment
The Food and Drug Administration (FDA) has approved Ekterly ® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.