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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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Europe approves Roche’s Tecentriq liver cancer combination

pharmaphorum

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

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Contents

RX Note

Drug-Food Interactions - Predominantly the effect of food on absorption Drugs and Pregnancy - Discussing FDA Pregnancy and Lactation Final Rule and Australian Categories for Prescribing Medicines in Pregnancy Drugs and Lactation - Discussing key references Dosing in Obese - One dose fits all?