Drug Topics

JUNE 26, 2025

The study also showed the therapy’s safety profile was consistent with its current label. 1 Data from the study were presented at the American Diabetes Association’s 85th Scientific Sessions, which were held June 20-23 in Chicago, Illinois. No new side effects or adverse events were identified during the trial.

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Drug Topics

JULY 7, 2025

2 One of the risks of SGLT2is has been an increase in hematocrit levels, ranging from 2.3% in clinical trials, according to a case series published in Endocrine Abstracts.

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Compounding Patient Care Specialty Pharmacies FDA 190

Drug Topics

JUNE 25, 2025

The study is an open-label cohort trial aimed at evaluating the safety, tolerability, and early efficacy of Revita for patients who lost at least 15% or more of their total body weight with a recently discontinued GLP-1.

HIV Treatment and Prevention Agents 281

HIV Treatment and Prevention Agents Compounding Specialty Pharmacies Independent Pharmacies 281

Drug Topics

JULY 10, 2025

MK-8591A-051 is a randomized, active-controlled, open-label phase 3 study evaluating the safety, tolerability, and antiretroviral activity of a switch to doravirine/islatravir compared with continued baseline antiretroviral therapy.

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Pharmacy Times

JUNE 20, 2025

Oncology pharmacy practice changes at a rapid pace. There are too many drug approvals, label updates, and new data published for even the most skilled and experienced oncology pharmacist to keep up with, let alone those still building their baseline knowledge. Fifteen years ago, pharmacists could learn oncology on the job.

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Compounding Compounding Pharmacies Patient Care Immunization 115

Pharmacy Times

JUNE 23, 2025

Along with the successful pivotal trials, Launch-HTN and Advance-HTN, and the ongoing open-label extension trial, these results comprise the core package for our planned NDA submission.” Explore-CKD established that lorundrostat 25 mg once daily has a favorable clinical profile for this patient population.

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Pharmacy Times

JUNE 30, 2025

Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. Still, providing accurate product labeling for these products—which properly conveys the risks of CRS and neurological toxicities—remains essential to ensuring patient safety.

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Pharmacy Times

JUNE 30, 2025

2-5 In the multicenter, phase 2, open-label prospective study, researchers investigated ropeg-IFN-α2b treatment in patients with profibrotic MF or DIPSS low-intermediate-1 risk MF. With phase 3 trial win, PharmaEssentia plots label expansion for rare blood cancer treatment Besremi. Updated November 30, 2023. Accessed June 30, 2025.

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Compounding Pharmacies Immunization Compounding Hospitals 86

Pharmacy Times

JUNE 20, 2025

In general, choosing a product that has broad spectrum on the label, covering both UV-A and UV-B rays and containing 20% zinc oxide, for her children will be optimal, especially for more sensitive areas of the skin. Whereas SPF 15 blocks approximately 93% of UV-B rays, SPF 30 and SPF 50 increase coverage slightly (97% and 98%, respectively).

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Compounding Pharmacies Immunization FDA Hospitals 97

Pharmacy Times

JUNE 23, 2025

In 2024, the FDA granted datopotamab a breakthrough therapy designation for patients with NSCLC based on data from the TROPION-Lung05 and TROPION-Lung01 trials that have since led to the agent’s accelerated approval.

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FDA Compounding Pharmacies Chemotherapy Immunization 86

Pharmacy Times

JULY 3, 2025

Typically, it's a white-labeled experience, so it has the look and feel of that digital therapeutic throughout the entire experience. Pharmacy Times : What is the future role of pharmacists as digital prescriptions become standard care?

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Compounding Pharmacies FDA Immunization Packaging 81

Pharmacy Times

JUNE 30, 2025

2,3 LIMBER is a phase 1, open-label, dose escalation study evaluating INCB057643 as a monotherapy at a dose escalation of 4 to 12 mg daily (part 1) or in combination with ruxolitinib at a dosage of 4 mg once daily and escalating to the maximum tolerated dose in part 1 (part 2). Subscribe Now!

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Pharmacy Times

JUNE 23, 2025

1 Image credit: Cynthia | stock.adobe.com The discussion featured Vivian Fonseca, MD, of the Tulane University School of Medicine, who presented an overview of tirzepatide based on the FDA-approved label and clinical guidelines. He was joined by Laura, a patient who began tirzepatide treatment shortly after being diagnosed with T2D.

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HIV Treatment and Prevention Agents Compounding Pharmacies Immunization FDA 81

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).

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Compounding Pharmacies FDA Immunization Mayo Clinic 65

Pharmacy Times

JULY 1, 2025

1 To evaluate how temperature information is stored in the mouse brain, researchers designed a thermoregulatory Pavlovian conditioning experiment using engram labeling technology, which is a physical change in the brain that accounts for a specific memory. 1 The study included trained mice in context A at 21 °C and in context B at 4 °C.

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Compounding Pharmacies Immunization Labelling Specialty Pharmacies 65

Pharmacy Times

JUNE 23, 2025

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.

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FDA Compounding Pharmacies Dosage Hospitals 65

Pharmacy Times

JUNE 11, 2025

1,2 Image Credit: © stockdevil - stock.adobe.com Results from 2 single-dose, open-label, randomized phase 1 crossover studies of healthy adults served as the basis for this approval. These trials were designed to establish bioequivalence between zanubrutinib capsules and zanubrutinib tablets.

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FDA Compounding Pharmacies Immunization Specialty Pharmacies 73

Pharmacy Times

JUNE 11, 2025

Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). Taletrectinib is an oral, potent, central nervous system (CNS)–active, selective, next generation ROS1 inhibitor approved for the treatment of adults with advanced ROS1+ NSCLC.

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Pharmacy Times

JUNE 9, 2025

months versus 2.1 The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, which was held in Chicago, Illinois. It is the first PROTAC to be evaluated in a phase 3 clinical trial, according to the investigators.

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Compounding Pharmacies Immunization Hospitals Compounding 73

Pharmacy Times

JULY 10, 2025

If approved, lumatperone’s expanded label could offer health care teams a valuable tool to improve stability, well-being, and real-world outcomes for patients with schizophrenia. 1-3 REFERENCES 1. Johnson & Johnson.

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Pharmacy Times

JUNE 9, 2025

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. But doing so requires a new kind of expertise that spans science, strategy, and systems thinking.

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Compounding Pharmacies FDA Hospitals Immunization 56

Pharmacy Times

JULY 2, 2025

2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis. The trial’s primary objective was to evaluate the tolerability of OLC at its clinically effective doses (goal: serum phosphate ≤ 5.5

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FDA Compounding Pharmacies Vaccines Immunization 73

Pharmacy Times

JULY 10, 2025

News All News FDA Updates Press Releases Media All Videos Digital Detail Independent Corner Insights Interviews MEDcast Medical World News Microsites Peer Exchange Perfect Consult Podcasts Practice Pearls Sponsored Webcast Student Voices Webinars/Webcasts Conferences Conference Coverage Conference Listing Publications Pharmacy Times Pharmacy Practice (..)

Specialty Pharmacies 65

Specialty Pharmacies Vaccines Immunization Compounding Pharmacies 65

Pharmacy Times

JUNE 12, 2025

Primary chemoablation of recurrent low-grade intermediate-risk nonmuscle-invasive bladder cancer with UGN-102: A single-arm, open-label, phase 3 trial (ENVISION). Prasad SM, Shishkov D, Mihaylov NV, et al. February 1, 2025. doi:10.1097/JU.0000000000004296 0000000000004296 4.

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

Labelling 65

Labelling FDA Compounding Pharmacies Independent Pharmacies 65

Pharmacy Times

JULY 1, 2025

Additionally, tafamidis stands out compared with other TTR stabilizers that are used off-label and require monitoring for renal and gastrointestinal AEs. Additionally, pharmacists are also vital in identifying financial assistance programs or navigating specialty pharmacies or mail-order services.

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HIV Treatment and Prevention Agents Specialty Pharmacies Compounding Pharmacies Hospitals 111

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.

Mayo Clinic 106

Mayo Clinic Compounding Pharmacies Immunization Compounding 106

Pharmacy Times

JUNE 9, 2025

3 neoCARHP was a multicenter, open-label, randomized, noninferiority phase 3 trial (NCT04858529) that compared the efficacy and safety of TCbHP with THP in the neoadjuvant setting. If caught early, the cancer can often be treated and cured, according to Cleveland Clinic. Gao HF, Li W, Wu Z, et al. J Clin Oncol. doi:10.1200/JCO.2025.43.17_suppl.LBA500

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Pharmacy Times

JUNE 12, 2025

Molecular model of pembrolizumab | Image Credit: © Dr_Microbe - stock.adobe.com The FDA’s decision was based on data from the randomized, multicenter, open-label KEYNOTE-689 trial (NCT02358031). This marks the first FDA approval for a perioperative treatment approach in locally advanced HNSCC.

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Pharmacy Times

JUNE 27, 2025

Although no formal contraindications are listed in AstraZeneca’s US labeling, perioperative management may require holding acalabrutinib 3 to 7 days before and after surgery to minimize bleeding risk. Hepatotoxicity and drug-induced liver injury are additional risks that require monitoring.

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FDA Compounding Pharmacies Immunization Chemotherapy 56

Pharmacy Times

JUNE 9, 2025

These conclusions were presented as part of an abstract from the open-label, phase 3 CheckMate 816 trial (NCT02998528) at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, and subsequently published in the Journal of Clinical Oncology.

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Chemotherapy Compounding Pharmacies Immunization Compounding 65

Drug Topics

JUNE 12, 2025

The FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret) to treat acute hepatitis C virus (HCV) infection in patients 3 years of age and older with compensated cirrhosis or without cirrhosis, AbbVie announced in a release.

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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.

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Pharmacy Times

JULY 7, 2025

Limitations included open-label design and dosage constraints, but the multicountry approach enhanced generalizability and external validity. 1 “The limitations of this study were it being open-label, allowing potential assessment biases and the absence of blinded assessment of clinical endpoints. Additionally, SOCs with at least 2.5%

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Compounding Pharmacies Dosage Labelling Immunization 98

Pharmacy Times

JUNE 5, 2025

Detect-A-Dose lid-label cover enhances medication recognition, reducing packaging errors through a contrasting visual pattern. 1-3 Detect-A-Dose Lid Label Covers. 4 Detect-A-Dose features a contrasting black and white pattern on the underside of its label to make missing doses for patients apparent to pharmacists.

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Packaging Labelling Compounding Pharmacies Immunization 65

Pharmacy Times

JUNE 16, 2025

1 As part of another action designed to reduce drug costs, Newsom also announced the expansion of CalRx, the state’s initiative to produce generic drugs under the state’s own label, giving CalRx the authority to purchase brand-name drugs. Furthermore, DMHC would have clear authority to enforce rules and penalize violations.

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