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By tailoring your pharmacy to meet the needs of customers across both prescription and over-the-counter (OTC) products, you can transform your store into a long-term community destination for total health and wellness. Private-label brands allow you to deliver the same quality as larger name brands, often at a lower cost. April 2025.
of YA with obesity were prescribed OMs—predominantly GLP-1s approved for adults but used off label for younger people. Despite the high prevalence of obesity among children and YA, OM utilization remains low,” wrote authors of the abstract. 1 In the final year of the analysis (2024), just 1.5% of adolescents and 5.7%
After the randomized portion of the study, patients were eligible to enroll in an open-label extension study for 3 months to assess the long term safety of PP405. Patients applied the therapy or placebo once per day for 4 weeks and were followed for up to 12 weeks.
Image Credit: sonyakamoz - stock.adobe.com "We have been conditioned to equate weight loss with health, and weight loss-resistant individuals are often labeled as failures,” Anat Yaskolka Meir, PhD, postdoctoral research fellow in the department of epidemiology at Harvard Chan School, said in a news release.
In an open label extension trial, after 72 weeks, the response to omaveloxolone compared to placebo was maintained. The post FDA approves omaveloxolone for treatment of Friedreich’s Ataxia appeared first on Hospital Pharmacy Europe.
Mounjaro (tirzepatide) is a brand-name prescription medication that’s approved by the Food and Drug Administration (FDA) to lower blood sugar levels in people with Type 2 diabetes. Blue Cross Blue Shield doesn’t typically cover Mounjaro for weight loss because it’s considered an off-label use of the drug. How much does Mounjaro cost?
Dupixent (dupilumab) is a brand-name monoclonal antibody drug that is approved by the Food and Drug Administration (FDA) to treat a variety of conditions. However, it’s shown some versatility in recent studies , so doctors might prescribe it off-label for other skin conditions that aren’t FDA approved.
Food and Drug Administration (FDA) to treat obesity in the short term and is meant to be combined with exercise, calorie reduction, and behavioral modifications. This is largely a historical remnant because phentermine was originally FDA-approved in the 1950s for short-term use,” Dr. Garcia-Webb explains. It’s approved by the U.S.
The FDA has accepted for review a New Drug Application (NDA) for doravirine/islatravir for adult patients with HIV-1 infection that is virologically suppressed on antiretroviral therapy, Merck announced in a release. 1 The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. References 1.
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.
The drugs can prevent reabsorption of filtered glucose from the tubular lumen. 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.
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.
Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. SHOW MORE FDA removes REMS for CAR T-cell therapies, enhancing patient access while ensuring safety in cancer treatment. Only some medications—including CAR T therapies—carry REMS designations.
The FDA's decision represents progress in treating EGFR-mutated NSCLC beyond initial therapy lines. SHOW MORE Datopotamab deruxtecan gains FDA approval, offering new hope for adults with advanced EGFR-mutated non-small cell lung cancer after prior therapies.
The FDA approved taletrectinib (Ibtrozi; Nuavtion Bio Inc) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non–small cell lung cancer (NSCLC). It demonstrated high response rates with durable benefit and intracranial activity and was well-tolerated among patients, according to the FDA.
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.
A recent supplemental new drug application (sNDA) submitted to the FDA seeks to expand lumapeterone’s approval based on compelling relapse prevention data. A recent supplemental new drug application (sNDA) submitted to the FDA seeks to expand lumapeterone’s approval based on compelling relapse prevention data. 1-3 REFERENCES 1.
In an interview with Pharmacy Times®, Areo Nazari, PharmD, CEO at CaryHealth, discussed how prescription digital therapeutics (PDTs) are FDA-approved, software-based treatments that offer alternatives or complements to traditional therapies. Pharmacy Times: Can you give a brief overview of PDTs?
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).
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. Pharmacy Times. FDA approves ropeginterferon alfa-2b-njft for polycythemia vera. Accessed June 30, 2025. June 3, 2025. Accessed June 30, 2025.
Unicycive plans to resolve FDA concerns by utilizing a second manufacturing vendor with a successful regulatory history to address manufacturing-related issues. 2,4 The open-label, single-arm, multicenter, multidose study enrolled 86 patients with CKD and hyperphosphatemia receiving maintenance hemodialysis. 1 REFERENCES 1.
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.
The Orange Book is the reference, and it allows the FDA to declare something [to be] therapeutically equivalent. The FDA Approval Process Within the FDA approval process, the 505(b)(1) new drug application (NDA) submission pathway is the pathway by which new drugs are able to seek approval.
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. Pharmacy Times Staff. FDA Approves Tirzepatide Injection for Adults With Type 2 Diabetes.
Nemolizumab targets IL-31 receptor alpha, inhibiting itch and inflammation, and is FDA-approved for use with topical therapies in patients 12 and older. Nemolizumab also received FDA approval in August 2024 as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. Pharmacy Times.
Mitomycin intravesical solution (Zusduri, UroGen Pharma) was approved by the FDA for treatment of adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
Patient organisations have been celebrating the FDA approval yesterday of Amylyx’ amyotrophic lateral sclerosis (ALS) therapy Relyvrio, after not one but two advisory committee meetings that arrived at different conclusions about the drug. The post Relief for Amylyx as FDA clears controversial ALS drug Relyvrio appeared first on.
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.
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).
Dalton shared her surprise about how variability in manufacturing affects the patient experience, given that some products created using the patient’s cells may not always be usable or up to FDA standards. Presented at: American Society of Health-System Pharmacists 2025 Pharmacy Futures. REFERENCES 1. Updated March 20, 2023.
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.
BCPS, Lead Clinical Pharmacy Specialist at KSP SpecialtyPharmacy. This can reduce stomach upset unless your medication is labeled “enteric coated” or “gastro-resistant.” Herbal supplements are not regulated by the FDA, so the full extent of interactions with drugs like prednisone is unknown.
The Food and Drug Administration (FDA) has approved Fasenra for maintenance treatment of severe asthma. Nucala has a more robust array of indications and has been FDA approved to treat severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic conditions, and rhinosinusitis with nasal polyps.
Medication Adherence Requires Personalized Communication Alva emphasized that effective counseling about medications—especially those with intimidating FDA warnings—requires compassionate, patient-centered communication.
SHOW MORE FDA approves a new dosing schedule for donanemab, enhancing safety and efficacy in treating early symptomatic Alzheimer disease. This advancement provides healthcare professionals with improved confidence in managing Alzheimer's disease with donanemab. million individuals in the United States aged 65 and older.
SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. Mann School of Pharmacy and Pharmaceutical Sciences. For this application, the FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Switzerland’s Swissmedic.
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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 specialtypharmacies or mail-order services. Pharmacy Times.
SHOW MORE The FDA has approved Y-90 resin microspheres (SIR-Spheres; Sirtex Medical), a radioembolization therapy for the treatment of unresectable hepatocellular carcinoma (HCC), which is marked as the most common form of liver cancer in adults residing in the US. The DOORwaY90 study showed a 98.5% " 1 REFERENCES 1. News release.
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. 3 READ MORE: Infectious Disease Resource Center Pharmacy practice is always changing.
The ADVANTAGE AF trial supported the FDA approval, showing 99.7% 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.
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
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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