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Diabetes Labelling Specialty Pharmacies 
Pharmacy Times
JUNE 27, 2025
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.
Pharmacy Times
JUNE 16, 2025
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).
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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 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 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 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 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. Additionally, pharmacists are also vital in identifying financial assistance programs or navigating specialty pharmacies or mail-order services.
Pharmacy Times
JULY 15, 2025
months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results.
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 (..)
Pharmacy Times
JULY 7, 2025
Risk factors that could increase the development of HCC, along with chronic liver conditions, include older age, excess fat in the liver, diabetes, obesity, exposure to aflatoxins, excessive alcohol consumption, and cigarette smoking. 2 "The expanded indication makes SIR-Spheres ® the only Y-90 treatment approved in the U.S.
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. Pharmacists’ involvement in these areas is crucial, from patient education and dose adjustment to monitoring outcomes.
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 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 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.
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 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 Times
JULY 15, 2025
What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.
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.
26 
Pharmacy Times
JULY 7, 2025
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.
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 Times
JUNE 23, 2025
It is not indicated for type 1 diabetes and carries a boxed warning for thyroid C-cell tumors, with unknown risk in humans. The presentation emphasized early intervention and personalized treatment plans in managing type 2 diabetes, shifting from "treating to failure" to "treating to target.
32 
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 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 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. Pharmacy Times : What is the future role of pharmacists as digital prescriptions become standard care?
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 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 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 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 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.
26 
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 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 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 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 Times
JUNE 9, 2025
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 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.
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.
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.
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.
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.
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. The update aims to enhance AF treatment with safe, effective ablation technologies, with future trials planned for more complex arrhythmias.
26 
The Nontraditional Pharmacist
SEPTEMBER 9, 2019
And so I did internships during school in managed care pharmacy, I did coming out of pharmacy school a residency a managed care pharmacy where you’re really rotating through learning about all sorts of different areas within the health plan. During the residency I got a lot of good experience there.
Putting Patients First Blog
JULY 2, 2024
Similarly, long-acting insulin analogs provide more stable blood sugar control and reduce the number of daily injections needed for diabetes patients. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines. Health Affairs, 38(11) , [link] v Durham, D.,
52 
Putting Patients First Blog
JANUARY 27, 2025
3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. However, we urge CMS to consider broadening eligibility criteria to include individuals who are overweight but have not yet developed these conditions.
BioPharma Dive
JULY 21, 2025
Despite knowing about the most recent patient death for weeks, and having already discussed Elevidys labeling changes with Sarepta, the agency on Friday asked Sarepta to stop shipping the drug to Duchenne patients. Company Announcements View all | Post a press release Cycle Pharmaceuticals Selects LeMed Specialty Pharmacy as Exclusive U.S.
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