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Simple techniques, such as color-coding or clearly labeling insulin pens and vials with a marker can help patients remember which insulin to use and when. Mealtime insulin must be taken close to eating, ranging from 30 minutes before to just after the meal, depending on the product.
Private-Label Partnerships can Streamline Operations and Enhance the Customer Experience Offering a broad selection of private-label OTC products can help your pharmacy stay competitive and support your customers’ evolving needs. Private-label brands allow you to deliver the same quality as larger name brands, often at a lower cost.
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. Accessed June 12, 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.
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. Cancer Therapy Advisor. June 21, 2024.
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).
EP426 Recent Videos Related Content GLP-1s Effective as Adjunctive Therapy in Patients with T1D, Obesity | ADA 2025 Brian Nowosielski July 2nd 2025 Article Researchers explored patients with type 1 diabetes and overweight or obesity to understand the efficacy and safety of GLP-1s as adjunctive therapies. g/dL in hemoglobin and a 1.4%
Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies. REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management.
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.
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.
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.
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. months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results. Doi:10.1182/blood.2025029274
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.
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.
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.
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.
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.
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.
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
Limitations included open-label design and dosage constraints, but the multicountry approach enhanced generalizability and external validity. The phase 3 trial demonstrated comparable safety profiles between efepoetin alfa and Mircera, with a slightly higher response rate for efepoetin alfa.
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.
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% 2024;331(23):2041–2043.
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.
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.
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. The dual targeting brings the T cell in close proximity to the B cell and then activates the release of proteins from the T cell that kill cancer cells. “We
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.
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.
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.
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.
Companies marketing unapproved or misbranded products, such as dietary supplements and topical analgesics, were warned for noncompliance with labeling and authorization rules. The products, labeled “Silver Bullet elite douche” and “Silver D elite douche,” contain colloidal silver intended for use in treating vaginal infections.
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
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. 1 The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. Subscribe Now!
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).
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.
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. Accessed June 26, 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).
Over the years, Ive come across a number of ways to naturally prevent and treat UTIs, and Im sharing them in this article. Please also see this article for more information about the most beneficial probiotics that I recommend for Hashimotos. See my article on oxalates for more information.
1] This inability to detox properly can trigger or worsen autoimmune symptoms, as these chemical exposures can trigger immune dysregulation. [2] to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), From indoor pollutants like formaldehyde (yes, really!),
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. 1 The company said it plans to initiate phase 3 studies in 2026 to further evaluate the therapy.
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.
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