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.

FDA

Pharmacy Times

JULY 15, 2025

months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results. months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results.

Immunization

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. In addition to efficacy and safety, the investigators aim to provide valuable information on functional capacity and survival in this open-label extension.

HIV Treatment and Prevention Agents

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.

FDA

Pharmacy Times

JULY 22, 2025

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.

Compounding Pharmacies

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. Cal Matters.

Compounding Pharmacies

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.

Compounding

Pharmacy Times

JULY 17, 2025

1 Image Credit: Syahrir | stock.adobe.com Gabapentin is FDA approved for partial seizures and postherpetic neuralgia, but has widespread off-label use for various chronic pain conditions, including back pain.

Compounding Pharmacies

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

FDA

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%

Compounding Pharmacies

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.

Packaging

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.

Compounding Pharmacies

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.

Compounding Pharmacies

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.

HIV Treatment and Prevention Agents

Pharmacy Times

JULY 18, 2025

1 STARGLO is an open-label, multicenter, randomized phase 3 STARGLO clinical trial which compared the efficacy and safety of glofitamab and GemOx (Glofit-GemOx) with rituximab (Rituxan; Genentech) and GemOx (R-GemOx) in patients with R/R DLBCL who have received at least 2 prior lines of treatment.

FDA

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.

FDA

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.

Compounding Pharmacies

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.

FDA

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

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

Compounding Pharmacies

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).

Compounding Pharmacies

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).

Compounding Pharmacies

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.

FDA

Pharmaceutical Commerce

JULY 16, 2025

This gap in the market has created a "gold rush" for compounding pharmacies and new startups. These entities have stepped in, offering seemingly cheaper 2 and more readily available compounded alternatives to fill the void. Subscribe Now!

Compounding

Pharmacy Times

JUNE 9, 2025

months versus 2.1 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.

Compounding Pharmacies

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.

FDA

The Checkup by Singlecare

MARCH 10, 2025

Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. The cost of semaglutide can vary on whether youre getting a brand-name or compounded version and whether you have insurance coverage. Learn more from our article on how to get Wegovy covered by insurance.

Compounding

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

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.

FDA

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.

Compounding Pharmacies

Pharmacy Times

JULY 21, 2025

" 1 ALKAZAR is a global, randomized, controlled, open-label phase 3 trial studying neladalkib in TKI-naïve patients with advanced ALK-positive NSCLC. About 450 patients will be enrolled and randomly assigned to receive either 150 mg of neladalkib orally once per day or 600 mg of alectinib (Alecensa; Genentech) orally twice per day.

Compounding Pharmacies

Pharmacy Times

JULY 30, 2025

3 Gedatolisib’s efficacy and safety were demonstrated in the phase 3, open-label, randomized VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Compounding Pharmacies

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. News release. July 7, 2025. Accessed July 7, 2025. Mayo Clinic. Atrial fibrillation.

Labelling

The Thyroid Pharmacist

JUNE 30, 2023

In this article, you will learn: What low dose naltrexone, or LDN, is How LDN benefits Hashimoto’s Potential side effects The Root Cause approach vs. conventional treatment Where to find LDN and how to take it What Is LDN? Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses.

Compounding

The Checkup by Singlecare

MARCH 21, 2024

adults have been turning to Canadian pharmacies for more affordable prices—but shortages and restrictions have made that option increasingly less feasible. In this article, we’ll cover how much some have saved, if this method is safe and legal, and the issues with U.S. While there are several ways to save on Ozempic, U.S. mg, and 2.4

Insurance Coverage

OctariusRx

AUGUST 8, 2022

Not just checking for expired medications, but all storage requirements including temperature, labeling and infection control. Helping assess compounding pharmacies when compounded medications are needed. Has the consultant published any articles in professional or clinical practice journals?

Controlled Substances

The Checkup by Singlecare

JUNE 21, 2023

At this time, Ozempic does not have FDA approval for weight loss, but it may be prescribed off-label for this purpose. There are compounded versions of injectable semaglutide available from compounding pharmacies, but these have not been tested by or approved by the FDA. Is Ozempic good for PCOS?

Insurance