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
The US Food and Drug Administration (FDA) has expanded the indications of an imaging agent developed by GE HealthCare, which will likely put it at the forefront of the Alzheimer’s diagnostics arena. Last month, the FDA approved the Lumipulse G test , the first blood test to help diagnose the disease.
Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. Both vets urge dog owners to keep the medication out of reach of the petlike in a locked cabinet, for exampleand to follow the prescription label carefully.
Its not safe or effective, according to the Food and Drug Administration (FDA), and it may lead to serious health problems. Although these medications are effective, the FDA has not yet approved generic versions, meaning people can only get a prescription for semaglutide under its brand name. Is compounded semaglutide safe?
Pharmaceutical options such as benzodiazepines like diazepam and antidepressants like trazodone are sometimes used off-label to treat insomnia in adults. Food & Drug Administration (FDA) to treat generalized anxiety disorder. Previously sold under the brand name BuSpar, its main purpose is to alleviate symptoms of anxiety.
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 (..)
In children, the Food and Drug Administration (FDA) has approved azithromycin to treat ear infections, throat and sinus infections, tonsillitis, and community-acquired pneumonia (a type of pneumonia caught outside of a hospital setting). It’s available as a generic drug or under the brand name Zithromax.
What are the regulatory constructs that the FDA puts out in front of you to get there? And then how do you develop documents to basically get approval from the FDA to study your drug in humans? There’s a lot of other aspects that go along with it, but at a high level that’s roughly what that was.
Ozempic is the brand name for semaglutide, which is a medication thats FDA approved to treat high blood sugar in people with Type 2 diabetes. It is also often prescribed off-label as a weight loss medication, even in patients with normal blood sugars. Most people dont have this issue, but for those who do, it can feel unsettling.
SHOW MORE The FDA approved acalabrutinib as a frontline option for untreated mantle cell lymphoma. The FDA’s review of acalabrutinib was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that enables concurrent submission and review of oncology drugs across international regulatory agencies.
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.
REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management. Accurate product labeling and ongoing safety monitoring remain essential for patient safety in CAR T therapies.
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.
Relapse risk factors include prior hospitalizations, long illness duration, and antipsychotic polypharmacy, emphasizing the need for effective maintenance treatments. Maintaining stability in schizophrenia is a major clinical challenge—each relapse can disrupt functioning, burden caregivers, and elevate hospitalization risk.
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.
Tisento Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational oral medicine, zagociguat, for mitochondrial encephalomyopathy, lactic acidosis and stroke-like episodes (MELAS), a rare mitochondrial disease. Credit: Volha_R/Shutterstock.
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.
Tafamidis, a selective transthyretin stabilizer, significantly reduces mortality and hospitalizations in ATTR-CM patients. Tafamidis] was compared to placebo and reduced all-cause mortality by 30% and [cardiovascular] hospitalizations by 32% over 30 months.
months progression-free survival in real-world RRMM patients, consistent with KarMMa trial results. The data were published by Surbhi Sidana, MD, associate professor of medicine at Stanford University, et al in Blood.
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 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.
Food and Drug Administration (FDA) to help control blood sugar in patients with Type 2 diabetes. Ozempic has also shown promise as a weight-loss medication and is often prescribed off-label for this purpose. Ozempic (active ingredient semaglutide), a prescription medication manufactured by Novo Nordisk, is approved by the U.S.
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.
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.
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.
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.
Medication Adherence Requires Personalized Communication Alva emphasized that effective counseling about medications—especially those with intimidating FDA warnings—requires compassionate, patient-centered communication.
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.
Intelligent medication management systems using RWD help hospitals forecast demand, respond to crises, and minimize medication expiration and loss, ultimately improving patient care and operational efficiency. The FDA oversees over 23,000 prescription drug products approved for marketing in the US 1 and ultimately, an estimated 361.3
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.
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.
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.
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?
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. FDA approves ropeginterferon alfa-2b-njft for polycythemia vera. Accessed June 30, 2025. ASCO 2025 delivers insights into future of myelofibrosis care.
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.
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).
CPH, clinical pharmacy manager with HCA Florida Highlands Hospital. Its also used off-label to treat conditions like anxiety disorders, panic disorders, and symptoms of an overactive thyroid. It has a half-life of three to six hourshalf of the drug is eliminated from your system in this period.
At Children’s Hospital of Philadelphia (CHOP), eligible patients can access 12 advanced therapeutics and 8 more in the pipeline. 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.
The US Food and Drug Administration (FDA) has approved KalVista Pharmaceuticals’ Ekterly (sebetralstat) as the first and only oral on-demand medication for acute attacks of hereditary angioedema (HAE) in adults and in children aged 12 years and above. Credit: KalVista Pharmaceuticals/Business Wire.
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.
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. Of note, the adjuvant phase of the trial is currently ongoing.
Fentanyl is an opioid medication used as an anesthetic in hospital settings as well as a pain reliever (analgesic) both in and out of the hospital. Fentanyl used in healthcare settings is overseen by the FDA. According to its drug label, bupivacaine reaches very low levels three to six hours after administration.
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).
It can be prescribed off-label for certain types of pain, especially severe acute pain or pain caused by cancer. Fentanyl may also be prescribed off-label, meaning for a purpose other than what the Food and Drug Administration (FDA) approved it for. As of Sept. Why is fentanyl so dangerous? For example: A 2021 study of U.S.
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