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2019.04.011 Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. J Natl Med Assoc. 2019;111(5):540-545. doi:10.1016/j.jnma.2019.04.011 Subscribe Now!
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Importantly, Novavax received FDA approval in May 2025 with restrictions: It is approved for individuals 65 years and older and patients aged 12 to 64 years with at least 1 health condition that puts them at risk for severe COVID-19. link] US FDA approves BLA for Novavax’s COVID-19 vaccine. October 16, 2024. Accessed May 29, 2025.
Finerenone and the Future of Diabetes-Related Kidney Care Newsletter Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights. Subscribe Now!
14,15 Lung Cancer Tarlatamab Significantly Improves Survival in Patients With Small Cell Lung Cancer Post Progression Tarlatamab has shown promising efficacy in relapsed SCLC based on the initial single-arm trial findings, leading to an FDA approval in 2024, but challenges with administration have limited its widespread adoption.
The FDA has approved vancomycin injection, USP (Tyzavan; Hikma Pharmaceuticals PLC), for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections in adult and pediatric patients 1 month and older for whom appropriate dosing can be achieved.
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Historically, the FDA has required preclinical testing in animals to obtain safety and efficacy data for investigational new drugs (INDs) before they can begin clinical testing in humans. 3 More simply, the FDA is moving preclinical testing from in vivo animal models to in silico and in vitro methods.
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As this market surges toward unprecedented growth over the next decade, specialtypharmacies are increasingly turning to automation to meet demand and manage costs. Specialtypharmacies that prioritize efficiency over empathy risk missing what matters most: Meaningful connection during a critical moment in care.
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SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The phase 3 ECHO trial showed significant progression-free survival improvement with acalabrutinib, supporting its approval as a new standard of care for untreated MCL.
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SHOW MORE FDA removes REMS for CAR T-cell therapies, enhancing patient access while ensuring safety in cancer treatment. 1 Image Credit: ® Clayton - stock.adobe.com “The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving CAR T therapies.
Klein, MD, FRCP (C), FACC, FAHA, FASE, FESC, director at Pericardial Disease Center and professor of medicine, and Sean Krohn, PharmD, CSP, MSCS, lead clinical pharmacist, specialtypharmacy, discussed a complex case of severe pericarditis in an elderly patient who could not tolerate traditional treatments like NSAIDs or colchicine.
Looking Ahead: Finerenone and Future Recommendations As pharmacists await FDA approval of finerenone, many are already evaluating how this new agent might influence prescribing habits. That’s the key to titrating them to the target doses, promoting long-term medication adherence, and then monitoring for [adverse] effects,” Shah said.
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Nemolizumab targets IL-31 receptor alpha, inhibiting itch and inflammation, and is FDA-approved for use with topical therapies in patients 12 and older. Nemolizumab also received FDA approval in August 2024 as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis.
Transformative advances in continuous glucose monitoring and the impact of FDA over-thecounter approval on diabetes care. As accessible health care providers, pharmacists can educate patients on how to best use these devices, empowering them to take charge of their own health care. REFERENCES Afridi Z, Rauf SA, Ashraf SMN, Haque MA.
Related Videos Related Content Advertisement June 12th 2025 Mitomycin Intravesical Solution Receives FDA Approval for Non-Muscle Invasive Bladder Cancer Alexandra Gerlach, Associate Editor June 3rd 2025 S2. Subscribe Now!
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Updated March 28, 2025. Accessed June 6, 2025. Take Back Day. United States Drug Enforcement Administration. Accessed June 6, 2025. Drug disposal: drug take-back options. Updated October 31, 2024. Accessed June 6, 2025.
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SHOW MORE The FDA has approved a groundbreaking single-pill combination therapy for hypertension, enhancing cardiovascular health with triple-agent efficacy. The therapy provides a convenient single-pill regimen, potentially benefiting a broad range of patients, including those starting hypertension treatment.
SHOW MORE Avatrombopag gains FDA approval for pediatric ITP treatment, offering a new oral option for managing chronic thrombocytopenia in children. Common adverse reactions in pediatric patients included viral infections, nasopharyngitis, and cough, but the drug was generally well-tolerated.
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SHOW MORE The FDA approves dupilumab as the first targeted treatment for bullous pemphigoid, offering hope for patients with this debilitating skin condition. FDA officials approved dupilumab (Dupixent; Sanofi, Regeneron) for the treatment of adults with bullous pemphigoid (BP), marking the first and only targeted treatment for BP.
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A new drug application for lorundrostat is expected to be filed with the FDA in 2025. The most frequent dose limiting adverse effect is hyperkalemia which is dose-related with an incidence of 5% to 7%. mg/d, 1 mg/d, 2 mg/d, and placebo for 12 weeks. 17 The placebo-subtracted reductions in sBP were 8.1 mmHg (p = 0.003) and 11.0
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2 There are several FDA-approved adalimumab biosimilars—including interchangeable products—that are available to patients. They are biologic medications that are highly similar to their reference products without having any clinically meaningful differences.
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