The U.S. FDA cleared respiratory imaging technology company 4dmedical Ltd.’s computed tomography lung ventilation analysis software (CT LVAS) that is nearly identical to its X-ray velocimetry technology but uses CT imaging and provides greater access to the four-dimensional imaging technology.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medical, GE Healthcare, Medtronic, Pixyl, Supira Medical.
The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.
The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.
Hookipa Pharma Inc. has received clearance from the FDA for its IND application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.
The FDA has awarded orphan drug designation to Neoimmunetech Inc.'s NT-I7 (efineptakin alfa, rhIL-7-hyFc) for the treatment of acute radiation syndrome (ARS). NT-I7, a novel long-acting recombinant human IL-7, has the potential to rapidly recover and improve the immune response following a high dose of radiation exposure.
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
In October, U.S. FDA approvals experienced a significant upswing, reaching a total of 27 for the month, a 92.86% increase from 14 approvals recorded by BioWorld in September. In the initial 10 months of this year, FDA approvals hit 155, an increase of 22.05% from the 127 drugs approved last year, although approvals are down from 2018-2021. Approved new molecular entities are at 29 in 2023, up from 28 in the corresponding period last year but a decline from 2017-2021.
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