This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Using real-world data to support vaccine outreach and education Buy Reports Newsletters PT News GSK’s world-first gonorrhoea vaccine launched in England The immunisation programme aims to reduce rising gonorrhoea rates and address antibiotic-resistant strains. GSK’s 4CMenB is not a newly approved vaccine.
Professor Nazar adds that when it comes to research into chronic disease management, pharmacist-led studies have been shown to improve medication adherence and reduce hospital readmissions, while public health research involving pharmacists has demonstrated increased vaccination rates and contribution to antimicrobial stewardship.
Topics included innovative clinical services , vaccine access , and the interaction of pharmacology and nutrition. PharmaTalk sessions—dynamic conversations between pharmacy experts—featured thought leaders and pharmacy innovators sharing insights on the evolving health care landscape.
Labels now emphasize the risks of higher doses and caution against abrupt discontinuation in dependent patients to prevent withdrawal and other harms. SHOW MORE The FDA intends to update opioid labels to highlight risks of addiction, overdose, and interactions, enhancing safety in pain management practices.
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.
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.
They are kiosks that contain prescription medications, labeling equipment, and technology that can connect the patient to a remote pharmacist in real time. They can accept new or refill prescription orders, store medications, label and prepare prescriptions, and, at the discretion of a remote pharmacist, dispense prescriptions to patients.
A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. Amino acid composition ICH Q6B also requires that the overall amino acid composition of the product is investigated.
Beamion LUNG-1 is an open-label, phase 1 dose escalation trial evaluating zongertinib as a monotherapy in patients with advanced or metastatic small tumors; in this case, those with unresectable or metastatic, nonsquamous NSCLC with HER2 TKD mutations.
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).
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.
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.
While treatments for infection, inflammation, high eye pressure, and neovascularization have been shown to be effective, this method of delivery is considered “off-label,” as FDA has not approved products specifically for this use, except two intracameral implants (see below). In addition, many patients are hesitant to receive eye injections.
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.
That gives patients enough time to get any vaccines or medications they may need (depending on their destination), and plenty of time to refill routine medications. Depending on the country they’re headed to, certain travel vaccines, such as hepatitis B, typhoid, chikungunya, or yellow fever, may be recommended or even required.
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.
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.
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.
Thakar Varanya Chaiyaperm View All News Article Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling. Part two discussion describes a simple medication order and demonstrates calculations and labeling for each bulk drug type. Pluta Nishant B. Mole calculations.
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.
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.
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
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. Subscribe Now!
June 27, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Label updates have been approved for BMS’ CAR T cell therapies, Breyanzi and Abecma, to treat multiple myeloma. The regulatory agency has also given approval to the removal of the REMS requirement from the product labels. Credit: Saiful52 / Shutterstock.
And we also manage drug–drug interactions, verify vaccines are up to date, educate care teams on premedications to prevent infusion-related reactions. If a patient is transitioning from inpatient to an outpatient infusion center, we help coordinate continuity of care so we can avoid delays in any treatment.
This includes requirements for drug data storage and the maintenance of interoperable systems for sharing data, along with requirements for the data that must be stored on treatment labels. Together, these requirements create a foundation of RWD that stakeholders can leverage to improve supply chain operations and safety.
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%
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.
The label update refines language and streamlines the safety section by removing certain adverse events, aligning with placebo group occurrence rates. SHOW MORE The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein cholesterol management.
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.
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.
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.
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.
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.
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.
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.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content