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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.

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FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel

pharmaphorum

The most common adverse reactions seen in a trial cohort of 38,000 patients were at injection sites (84.1%) followed by fatigue (62.9%) and headache (55.1%), and serious adverse reactions occurred in 0% to 4.6% of participants.

Vaccines 111
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How advanced technology can streamline the COVID-19 vaccine rollout

pharmaphorum

The integration of real-time track and trace technology, handheld mobile smart devices and advanced analytics solutions into the COVID-19 vaccine rollout is our best shot to enhance the global vaccination effort and combat new variants with herd immunity. Adverse reactions to the vaccine. Critical supply chain visibility.

Vaccines 119
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FDA Approvals: September 2022 Recap

Digital Pharmacist

Common adverse reactions include conjunctival/ocular hyperemia, photophobia, blurred vision, dry eye, pain, headache, irritation, and visual impairment. . Its mechanism is due to an increase in aqueous humor drainage through the conventional and uveoscleral outflow pathways. Date of Approval: 9/21/2022.