Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries.
Brainspec Inc. received U.S. FDA 510(k) clearance for use of its artificial intelligence platform, Brainspec Core, in noninvasive measurement of brain chemistry using magnetic resonance spectroscopy (MRS).
“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTL Amedica, Icecure Medical, Zilia.
Carisma Therapeutics Inc. has received FDA clearance of its IND application for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor (CAR)-monocyte cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
Reports of T-cell malignancies, including lymphoma, have the U.S. FDA investigating the risks for patients who received certain autologous CAR T-cell immunotherapies.
As expected, Aldeyra Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA regarding its NDA for reproxalap in dry eye disease, with the agency requiring “at least one” additional study to prove efficacy of the reactive aldehyde species, or RASP, modulator.
With drug shortages becoming a fact of life, U.S. President Joe Biden said he plans to issue a presidential determination to broaden the Department of Health and Human Services’ (HHS) authorities under the Defense Production Act to enable investment in the domestic manufacturing of essential medicines, medical countermeasures and other critical inputs that the president deems essential to the national defense.
Springworks Therapeutics Inc.’s nirogacestat became the first drug indicated specifically for desmoid tumors, as well as the first gamma-secretase inhibitor to win marketing approval, winning a U.S. FDA nod on the anticipated PDUFA date of Nov. 27. Branded Ogsiveo, nirogacestat has breakthrough therapy, fast track and orphan designations.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inflammatix.
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