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FDA Mandates Major Opioid Label Revisions to Highlight Long-Term Risks

Pharmacy Times

3 The guideline presents 12 voluntary, evidence-based suggestions for opioid management. 4 It encourages increased use of nonopioid pharmacologic and nonpharmacologic therapies, initiation of immediate-release opioids only when necessary at the lowest effective dose, and frequent reevaluation of therapy goals, function, and risk.

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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

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Continuous Subcutaneous Lenalidomide Shows Promise in Reducing Toxicity in R/R Multiple Myeloma

Pharmacy Times

It will be interesting to see what dosage form these data prompt the future development of. It also introduces a question on how to optimize the PK/pharmacodynamic profile for protein degraders, such as cereblon E3 ligase modulatory drugs and proteolysis-targeting chimeras, which are a burgeoning area of therapeutic development.”

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Daily CBD Use at Consumer-Level Doses May Elevate Liver Enzymes, FDA-Led Trial Shows

Pharmacy Times

Animal studies reveal dose-dependent hepatic responses to CBD, supporting the need for cautious monitoring even at consumer-relevant dosages. Clinical trials show low-dose CBD can cause significant liver enzyme elevations in 5.6% of healthy adults, necessitating liver function monitoring.

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Pharmacists Can Simplify the Vaccine Schedule

Pharmacy Times

link] Seasonal influenza vaccine dosage & administration. September 17, 2024. Accessed May 29, 2025. link] RSV vaccine guidance for older adults. August 30, 2024. Accessed May 29, 2025. October 16, 2024. Accessed May 29, 2025. link] US FDA approves BLA for Novavax’s COVID-19 vaccine. News release. May 19, 2025. Accessed May 29, 2025.

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In the 505(j) ANDA approval pathway, on the other hand, submissions can be multisource generic drugs; however, this pathway requires bioequivalence to the RLD.