Remove Adverse Reactions Remove Labelling Remove Specialty Pharmacies
article thumbnail

How AI Brings Pharmacogenetics to the Frontline of Precision Medicine

Pharmacy Times

This change mirrored a January 2025 FDA safety alert and label update that urged providers to consider genetic testing, inform patients of the risks, and discuss available options. 5 In the biopharmaceutical industry, pharmacogenetics is increasingly employed to stratify patient populations and identify responders during drug development.

article thumbnail

FDA Issues Complete Response Letter to Manufacturer of OLC, Treatment for CKD-Related Hyperphosphatemia

Pharmacy Times

Common adverse reactions included gastrointestinal issues, with a low discontinuation rate due to adverse drug reactions. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer

Pharmacy Times

3 The safety profile was favorable with the most common adverse effect (AE) being increased creatinine, increased potassium, dysuria, decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, increased eosinophils, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria.

article thumbnail

Donanemab-Azbt Receives FDA Label Update With New Dosing for Alzheimer Disease

Pharmacy Times

The FDA has approved an updated label with a new recommended titration dosing schedule for donanemab-azbt (Kisunla; Eli Lilly and Company) for once-monthly amyloid-targeting therapy for adults that experience early symptomatic Alzheimer disease (AD). million individuals in the United States aged 65 and older.