Biosimilars Labelling Pharmacy Management 
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). Subscribe Now!
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Pharmacy Times
JUNE 30, 2025
REMS ensured drug safety by requiring certified hospitals to have tocilizumab for severe adverse events management. Increased experience in managing CAR T therapy toxicities has led to the removal of REMS, facilitating broader access.
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. In addition to efficacy and safety, the investigators aim to provide valuable information on functional capacity and survival in this open-label extension.
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