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Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs

MedCity News

The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products. The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

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Novartis halts recruitment of Kisqali trials as it adjusts production methods

Fierce Pharma

In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients in clinical trials of its blockbuster Kis | In response to recent FDA guidelines which limit the nitrosamine content of drugs, Novartis has paused the enrollment of early breast cancer (eBC) patients (..)

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As FDA weighs another myeloma endpoint for accelerated approvals, experts say timely access is at stake

Fierce Pharma

| At an FDA advisory committee meeting this Friday, two teams will present their studies examining the utility of minimal residue disease (MRD) as a potentially approvable endpoint in multiple myeloma.

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FDA Approves Benralizumab to Treat Pediatric Patients Aged 6 to 11 Years With Severe Asthma

Pharmacy Times

Benralizumab was previously approved by the FDA in 2017 as an add-on maintenance therapy for patients 12 years and older.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development? What will the future hold for clinical research?

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Innovative personalised immunotherapy approved for multiple myeloma

European Pharmaceutical Review

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Basis of the approval of the CAR-T therapy FDA’s approval of the personalised treatment is based on positive results from the Phase III CARTITUDE-4 study.

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FDA Approves Expanded Indication for Dovato to Include Adolescent Patients with HIV

PharmExec

OncLive serves as the connection to oncology, including groundbreaking cancer news and interviews with top oncologists in multimedia formats.