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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.

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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. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis.

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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

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.

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns.

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How advanced technology can streamline the COVID-19 vaccine rollout

pharmaphorum

Zebra Technologies healthcare lead Chris Sullivan discusses the COVID-19 vaccine rollout and how technology can streamline the process to combat new variants. . While the rollout of the COVID-19 vaccine has signified the first signs of light at the end of the tunnel, the reality is that this public health crisis is still far from over.

Vaccines 119
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BMS Submits Application for Abecma® for Relapsed or Refractory Multiple Myeloma

LifeProNow

The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA.