Labelling and Mayo Clinic - Pharmacist Digest

Nemolizumab Shows Rapid, Sustained Efficacy in Atopic Dermatitis

Pharmacy Times

JUNE 16, 2025

The findings emphasize nemolizumab’s swift response in treating atopic dermatitis symptoms, along with its long-term effectiveness in prurigo nodularis, as demonstrated in the OLYMPIA open-label extension trial (NCT04204616). Mayo Clinic. News release. June 6, 2025. Accessed June 16, 2025. Atopic Dermatitis. News release.

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Pharmacy Technician Compounding Pharmacies Biosimilars Pharmacy Management

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

Pharmacy Times

JUNE 23, 2025

“This act…allowed a pathway for manufacturers to create a ‘copy’ of a licensed patent product to make it cheaper and more discounted,” Soefje, director of pharmacy cancer care services and associate professor of pharmacy at Mayo Clinic in Rochester, Minnesota, said at the HOPA conference.

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FDA Approves Y-90 Resin Microspheres for Unrespectable Hepatocellular Carcinoma

Pharmacy Times

JULY 7, 2025

1 DOORwaY 90 Study Results The approval was supported by data from the prospective, multicenter, open-label, single-arm DOORwaY 90 study that evaluated the safety and efficacy of Y-90 resin microspheres in individuals with unresectable HCC. Mayo Clinic. News release. July 7, 2025. Accessed July 7, 2025. Liver cancer.

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Pharmacists Take the Lead on Advanced Therapeutics

Pharmacy Times

JUNE 9, 2025

Tichy, PharmD, MBA, vice chair of pharmacy formulary for Mayo Clinic, explained. 2 However, Dalton noted that some procedures can change once a treatment is FDA-approved, with complications from Risk Evaluation and Mitigation Strategy programs as well as the occasional surprise on an FDA label.

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Donanemab-Azbt Receives FDA Label Update With New Dosing for Alzheimer Disease

Pharmacy Times

JULY 9, 2025

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). Mayo Clinic. million individuals in the United States aged 65 and older.

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ASCO 2025: Cost-Effectiveness of Ribociclib in Early Breast Cancer

Pharmacy Times

JUNE 15, 2025

In the randomized, open-label, multicenter phase 3 NATALEE clinical trial (NCT05306340), ribociclib (Kisqali; Novartis) plus endocrine therapy, a nonsteroidal aromatase inhibitor (NSAI), significantly improved invasive disease-free survival among individuals with HR-positive (HR+) and HER2-negative (HER2-) early breast cancer.

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FDA Approves Expanded Labeling of Farapulse PFA System for Persistent Atrial Fibrillation

Pharmacy Times

JULY 14, 2025

SHOW MORE The expanded instructions for use labeling expand on the Farawave and Farawave Nav Pulsed Field Ablation (PFA) catheters. Boston Scientific receives FDA approval for expanded labeling of FARAPULSE™ Pulsed Field Ablation System. Mayo Clinic. News release. July 7, 2025. Accessed July 7, 2025. Atrial fibrillation.

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Over-the-Counter Choices Pharmacist Role and Resources

FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

Adverse Reactions

Adverse Reactions Dosage Mayo Clinic Medical Schools

Tenaya’s cardiomyopathy gene therapy gets fast track boost

Pharmaceutical Technology

MAY 3, 2023

With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. According to the Mayo Clinic, HCM refers to “a disease in which the heart muscle becomes thickened (hypertrophied)”. HCM is the most common inherited cardiac disorder.

Mayo Clinic

Mayo Clinic Labelling Communication

NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information

Putting Patients First Blog

DECEMBER 5, 2024

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 20 Specialized patient labeling should describe patient preferences for specific benefits and risks, tailored to the population most likely to use the device. 1 (2024): 159171.

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Labelling Communication Mayo Clinic

Approach to Fibrocystic Breasts with Hashimoto’s

The Thyroid Pharmacist

OCTOBER 25, 2022

Fibrocystic breasts used to be labeled as a disease, but given how common they are, they’re now simply referred to as “fibrocystic breasts.” (7) Mayo Clinic. The prevalence of benign breast diseases in patients with nodular goiter and Hashimoto’s thyroiditis. J Endocrinol Invest. 2015;38(9):971-975. Fibrocystic breasts.

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Compounding Mayo Clinic Labelling Immunization

ASH roundup: late breakers take the stage

pharmaphorum

DECEMBER 14, 2022

The company now intends to discuss the data with regulators, with a view to expanding Blincyto’s label. “Patients who are MRD negative have a better prognosis than patients who are MRD positive, generally, but they still relapse,” commented Mark Litzow of the Mayo Clinic, who presented the data at ASH.

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Industry group says FDA botched COVID-19 convalescent plasma guidance

pharmaphorum

AUGUST 27, 2020

Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could lead to “hundreds, if not thousands, of in-date, ready to transfuse CCP units across the country being rendered unusable.”.

Mayo Clinic

Mayo Clinic Labelling Communication Vaccines

Pharmacist Digest

Nemolizumab Shows Rapid, Sustained Efficacy in Atopic Dermatitis

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

Trending Sources

FDA Approves Y-90 Resin Microspheres for Unrespectable Hepatocellular Carcinoma

Pharmacists Take the Lead on Advanced Therapeutics

Donanemab-Azbt Receives FDA Label Update With New Dosing for Alzheimer Disease

ASCO 2025: Cost-Effectiveness of Ribociclib in Early Breast Cancer

FDA Approves Expanded Labeling of Farapulse PFA System for Persistent Atrial Fibrillation

Over-the-Counter Choices Pharmacist Role and Resources

Tenaya’s cardiomyopathy gene therapy gets fast track boost

NHC Submits Comments on FDA’s Draft Guidance for Voluntary Incorporation of Patient Preference Information

Approach to Fibrocystic Breasts with Hashimoto’s

ASH roundup: late breakers take the stage

Industry group says FDA botched COVID-19 convalescent plasma guidance

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