The U.S. FDA announced several new and updated recalls recently, including a new recall of incubators made by Wipro GE Health Pvt. Ltd., of Bangalore, India, which may be subject to an increased risk that the infant may fall out of the system.
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
Taiwan’s Formosa Pharmaceuticals Inc. and Aimmax Therapeutics, Inc. said the U.S. FDA approved APP-13007 (clobetasol propionate ophthalmic suspension 0.05%), a twice-daily corticosteroid eye drop for postoperative eye pain and inflammation.
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
Rhythm Diagnostic Systems SA received CE mark approval from EU authorities for Multisense, a wearable device that continuously monitors patients remotely. The company looks to market the device first in France and Germany.
Three U.S. federal government agencies announced that their focus on consolidation in health care markets may soon ramp up, given concerns that consolidation may be affecting the cost and quality of patient care.
China’s National Medical Products Administration (NMPA) cleared 40 novel innovative drugs in 2023, of which nearly half were cancer therapies, marking a significant increase from the 21 new class 1 drugs approved in 2022.
The EMA validated two marketing approval applications of Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s antibody-drug conjugate (ADC) datopotamab deruxtecan (dato-dxd) on Mar. 4, for two types of lung and breast cancer.
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
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