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

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.

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

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 14, 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 (..)

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

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 (..)

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. Cal Matters.

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. link] The views expressed in this article are the authors' own and do not reflect the views of their employer.

Pharmacy Technician

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

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

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

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

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

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 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

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

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.

Pharmacy Technician

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). Subscribe Now!

Pharmacy Technician

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).

Pharmacy Technician

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.

Pharmacy Technician

Pharmacy Times

AUGUST 7, 2025

TAI-SHAN5 is a phase 1, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with B-NHL. By targeting BTK and LYN, birelentinib inhibits tumor growth through interruption of BTK-dependent and -independent BCR-signaling pathways.

HIV Treatment and Prevention Agents

PharmaTech

JUNE 25, 2025

link] Recent Videos Related Content Looking Beyond mRNA-based COVID-19 Vaccines to Innovative Therapeutics Cheryl Barton June 24th 2025 Article mRNA technologies offer great promise in immunotherapy and non-immunogenic applications. Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L. Text sign showing Industry News.

Dosage

Pharmaceutical Commerce

JULY 16, 2025

1 In response to this immense demand, coupled with high costs and accessibility issues, compounded alternatives have emerged as a seemingly pragmatic solution. However, these compounded GLP-1s are creating a significant, often underestimated, legal, reputational, and financial minefield for startups and the broader life sciences industry.

Compounding

The Thyroid Pharmacist

MAY 15, 2025

Over the years, Ive come across a number of ways to naturally prevent and treat UTIs, and Im sharing them in this article. coli bacteria from adhering to the walls of the urinary tract, thanks to compounds called proanthocyanidins. [9] See my article on oxalates for more information. Do you experience frequent UTIs?

Immunity

Pharmacy Times

AUGUST 6, 2025

The CARTITUDE-1 trial reported a 98% overall response rate and significant progression-free survival, but experts urge caution in labeling cilta-cel as a cure. 1 Image Credit: LASZLO | stock.adobe.com However, despite these promising data, experts are cautious about labeling the therapy a cure.

Pharmacy Technician

PharmaTech

JUNE 26, 2025

in Innovation Contest for Hematologic Malignancy Treatments June 26, 2025 By Patrick Lavery News Article The company’s mocravimod, a novel oral S1P receptor, is being evaluated for its efficacy as an addition to CAR-T cell therapies. Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs Paul L. million (approximately US$1.99

Dosage

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.

Pharmacy Technician

PharmaTech

JULY 17, 2025

3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. Check out the full article here ! antineoplastics, allergens).

Compounding