PharmExec

AUGUST 1, 2025

New labels will include study summaries, improved dosage warnings, and information on overdose reversal agents to enhance patient and healthcare professional awareness. Label changes aim to promote safer, research-supported decision-making, with a 30-day window for industry recipients to submit updates for review.

Medication Labelling

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.

Pharmacy Technician

Pharmacy Times

JULY 22, 2025

In a sign of alixorexton’s tolerability, over 95% of patients who participated in this portion of the trial elected to join the ongoing 7-week, open-label extension.

Pharmacy Technician

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.

Pharmacy Technician

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.

Pharmacy Technician

Pharmacy Times

JULY 15, 2025

Immune effector cell–associated neurotoxicity syndrome was less common but observed in 28% (grade ≥3, 5%). months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results. Additionally, the authors reported a progression-free survival of 8.8 Doi:10.1182/blood.2025029274 Subscribe Now!

Pharmacy Technician

Pharmacy Times

AUGUST 12, 2025

Image Credit: catalin | stock.adobe.com STARGLO Trial Overview Study Design and Population STARGLO was a global, randomized, open-label, phase 3 trial enrolling 274 patients across 62 centers in 13 countries. Herein, we highlight sections of the STARGLO study protocol that are important to consider when operationalizing glofitamab-GemOx.

Pharmacy Technician

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 14, 2025

Difficile COPD COVID-19 Cardiovascular Health Cervical Cancer Cholangiocarcinoma Cholesterol Chronic Kidney Disease Chronic Lymphocytic Leukemia Classical Hematology Colorectal Cancer Continuous Glucose Monitoring Cough and Cold Depression Dermatology Diabetes Digestive Health Dry Eye Disease Epilepsy Eye Care Flu Future of Pharmacy Gastrointestinal (..)

Independent Pharmacies

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.

Pharmacy Technician

Pharmacy Times

AUGUST 7, 2025

Difficile COPD COVID-19 Cardiovascular Health Cervical Cancer Cholangiocarcinoma Cholesterol Chronic Kidney Disease Chronic Lymphocytic Leukemia Classical Hematology Colorectal Cancer Continuous Glucose Monitoring Cough and Cold Depression Dermatology Diabetes Digestive Health Dry Eye Disease Epilepsy Eye Care Flu Future of Pharmacy Gastrointestinal (..)

Long-Term Care Facilities

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.

Pharmacy Technician

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.

Pharmacy Technician

Pharmaceutical Technology

AUGUST 13, 2025

GlobalData pharma analyst Vinie Varkey says: “Brinsupri represents the first on-label non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shift away from use of antibiotics in this disease space.” However, until now, there has been no therapy specifically approved for the condition.

Packaging

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.

Pharmacy Technician

Pharmacy Times

JUNE 20, 2025

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. Oncology pharmacy practice changes at a rapid pace. Fifteen years ago, pharmacists could learn oncology on the job.

Pharmacy Technician

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

Pharmacy Technician

Pharmacy Times

JULY 10, 2025

Difficile COPD COVID-19 Cardiovascular Health Cervical Cancer Cholangiocarcinoma Cholesterol Chronic Kidney Disease Chronic Lymphocytic Leukemia Classical Hematology Colorectal Cancer Continuous Glucose Monitoring Cough and Cold Depression Dermatology Diabetes Digestive Health Dry Eye Disease Epilepsy Eye Care Flu Future of Pharmacy Gastrointestinal (..)

Pharmacy Technician

Pharmacy Times

JULY 15, 2025

Just to share a little bit more about our medication packets: these packets are labeled by date and time, and they come in a monthly pill dispenser box. Those packets come right out of the box, and you're able to tear them away.

Pharmacy Technician

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.

Chemotherapy

Pharmacy Times

AUGUST 12, 2025

Difficile COPD COVID-19 Cardiovascular Health Cervical Cancer Cholangiocarcinoma Cholesterol Chronic Kidney Disease Chronic Lymphocytic Leukemia Classical Hematology Colorectal Cancer Continuous Glucose Monitoring Cough and Cold Depression Dermatology Diabetes Digestive Health Dry Eye Disease Epilepsy Eye Care Flu Future of Pharmacy Gastrointestinal (..)

Diabetes

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%

Pharmacy Technician

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.

Pharmacy Technician

Pharmacy Times

AUGUST 7, 2025

1 Clinical Data Supporting Approval The FDA’s decision was based on pooled data from 50 adult and pediatric patients enrolled across 5 open-label US studies (ONC006 [NCT02525692], ONC13 [NCT03295396], ONC14 [NCT03416530], ONC16 [NCT05392374], ONC18 [NCT03134131]). The critical Phase 3 ACTION trial will offer further validation.

Pharmacy Technician

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.

Pharmacy Technician

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.

Pharmacy Technician

Pharmacy Times

JULY 18, 2025

It has 1 region that binds to CD3, a protein on T cells, a type of immune cell, and 2 regions that bind to CD20, a protein on B cells, which can either be healthy or malignant. Events that were considered consistent with immune effector cell-associated neurotoxicity syndrome occurred in 4 patients, all of which were concurrent with CRS.

Pharmacy Technician

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. What we do is create a very nice UI/UX digital experience so we can onboard patients, receive payment, and then hand them off to the digital therapeutic.

Pharmacy Technician

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.

Diabetes

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.

Pharmacy Technician

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.

Pharmacy Technician

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.

Pharmacy Technician

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

Pharmacy Technician

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).

Pharmacy Technician

Pharmaceutical Commerce

AUGUST 14, 2025

For a while, such stockpiling will leave the industry relatively immune to tariff actions, which have varied from week to week since the spring. This was an increase of 71% from February 2025, largely due to Trump’s tariffs,” which are yet to be imposed.

Insurance Coverage and Processing

Pharmaceutical Technology

AUGUST 7, 2025

The FDA’s decision to grant accelerated approval was based on an integrated efficacy analysis of 50 patients with recurrent H3 K27M-mutant diffuse midline glioma, chosen across five open-label studies. The safety of Modeyso was evaluated in 376 patients across four open-label clinical studies.

Adverse Reactions