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In this article an infectious diseases pharmacist discusses five interesting things to know about sulopenem (Orlynvah). In this article I will go intofive interesting things about solupenem. In case you are wondering, the FDA label does not list any hepatic dose adjustments. 2023 Jan 6;76(1):78-88. 2023 Jan 6;76(1):66-77.
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. Cancer Therapy Advisor. June 21, 2024.
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.
Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. From 2003 to 2023, 943 drugs were approved through the 505(b)(2) pathway. The 505(j) pathway is how you get a multisource generic. REFERENCE Soefje SA.
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. Published August 1, 2023. Pharmacy Times. Accessed July 22, 2025. Diagnosis and assessment of sleep and circadian rhythm disorders. J Psychiatr Pract. 2005;11(2):102-115.
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.
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. November 27, 2023.
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. April 28, 2023. News release. July 7, 2025. Accessed July 7, 2025. Mayo Clinic. Liver cancer.
3 However, before 2023, there was no approved RSV vaccine for adults, making infection control measures critical for preventing outbreaks, especially in medical facilities. RSV could worsen conditions like asthma, chronic obstructive pulmonary disease, or heart failure, leading to hospitalization or fatal outcomes.
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
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.
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. Pharmacist.
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.
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. Updated November 30, 2023. With phase 3 trial win, PharmaEssentia plots label expansion for rare blood cancer treatment Besremi. FiercePharma.
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.
Its efficacy was evaluated in the 2 multicenter, single-arm open-label phase 2 clinical trials TRUST-I (NCT04395677) 3 and TRUST-II (NCT04919811). Updated October 30, 2023. Accessed June 11, 2025. A Study of AB-106 in Subjects With Advanced NSCLC Harboring ROS1 Fusion Gene. ClinicalTrials.gov identifier: NCT04395677.
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.
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. Updated March 20, 2023. 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. 3 REFERENCES 1. News release.
In 2023, invasive breast cancer was predicted to affect more than 290,000 women, and of these cases, approximately 15% to 20% are projected to be HER2+ breast cancer. Updated November 7, 2023. This specific type shows high levels of the HER2 protein, which manages how cells grow and divide. J Clin Oncol. doi:10.1200/JCO.2025.43.17_suppl.LBA500
Challener News Article Hydrogels, drug-eluting contact lenses, and other implant technologies show real promise. 2023 39 (2), 102-116. This method of administration delivers ocular therapies directly into the anterior chamber of the eye, allowing for targeted delivery and resulting in enhanced bioavailability (3). link] Gautam, M.;
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). November 6, 2023. Wang ZQ, Zhang ZC, Wu YY, et al.
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).
TAI-SHAN5 is a phase 1, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with B-NHL. By targeting BTK and LYN, birelentinib inhibits tumor growth through interruption of BTK-dependent and -independent BCR-signaling pathways.
The CARTITUDE-1 trial reported a 98% overall response rate and significant progression-free survival, but experts urge caution in labeling cilta-cel as a cure. 1 Image Credit: LASZLO | stock.adobe.com However, despite these promising data, experts are cautious about labeling the therapy a cure.
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. Do you experience frequent UTIs?
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.
Elevidys is the product of many years of research into the deadly neuromuscular condition and, in 2023 , became the first and currently only gene therapy for the disease approved in the U.S. You can unsubscribe at anytime. The Food and Drug Administration’s clearance was controversial.
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