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New Frontline BTK Inhibitor Strategy Gains FDA Approval in Untreated Mantle Cell Lymphoma

Pharmacy Times

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The Value of a Medically Integrated Pharmacy to Maximize Cost Avoidance and Reduce Waste of Oral Oncolytic Medications

Pharmacy Times

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

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.

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Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using RWD

Pharmacy Times

A group of experts will present an encore abstract titled " Prevalence of Dosage Modifications and Impact on Response Milestone Among Patients With CML Treated With Imatinib Using Real-World Data " at the 2025 Oncology Pharmacists Connect (OPC) meeting in Austin, Texas, from June 19 to 20.

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Unicorns Don’t Exist: Rethinking the Generalist Model in Oncology Pharmacy

Pharmacy Times

They have a team of highly skilled distribution professionals who can juggle efficacy and safety checks along with compounding as if they were conductors of a world-class symphony. We need people to coordinate and track prior authorizations, write persuasive appeal letters, and keep patients updated.

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FDA Approves Meloxicam Injection For Moderate-to-Severe Pain in Adults

Pharmacy Times

1 "[Meloxicam injection] demonstrates our commitment to improving patient care by providing an alternate dosage form for pain management," Ron Scarboro, chief executive officer at Azurity Pharmaceuticals, said in a press release. December 21, 2004. Subscribe Now!

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CAR T and Beyond: The Expanding Pipeline and Promise of Cell Therapies

Pharmacy Times

Development Trends: Oncology at the Forefront Gene therapy currently ranks third among therapeutic focus areas, with 2151 compounds in development in 2024 ( Figure ). 2-4 In the United States, the FDA had approved 44 cell therapy products as of March 6, 2025. 6 CAR T-cell therapies continue to dominate the genetically modified space.