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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. OLC, a lanthanum-based phosphate binder, showed efficacy and tolerability in a phase 2 trial, with most patients achieving target serum phosphate levels.

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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.

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

Pharmacy Times

While no new adverse reactions were observed in this study, higher rates of hypersensitivity and infusion-related reactions were observed.

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Blujepa From GSK

Pharmacy Times

1,2 The most common adverse reactions are abdominal pain, diarrhea, dizziness, flatulence, headache, nausea, soft feces, vomiting, and vulvovaginal candidiasis. The use of gepotidacin in pregnancy and breastfeeding has not been evaluated. It has not been studied in patients younger than 12 years or who weigh less than 40 kg.