STAT
OCTOBER 28, 2024
This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.
STAT
OCTOBER 28, 2024
This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility , STAT explains. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharmacy Times
JUNE 27, 2025
Because of its aggressive nature, MCL is typically treated with combination chemotherapy at diagnosis. 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.
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
JUNE 20, 2025
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.
Pharmacy Times
JUNE 9, 2025
SHOW MORE Nivolumab (Opdivo) and chemotherapy demonstrated an overall survival benefit at 5 years, affirming its role as a standard of care option. 1,2 Nivolumab and chemotherapy is a standard of care option for resectable non-small cell lung cancer. months with the combination of nivolumab and chemotherapy, and 24.0%
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. Subscribe Now!
Expert insights. Personalized for you.
351 
Let's personalize your content