“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.
Inflammatix Inc. received U.S. FDA breakthrough device designation for its Triverity acute infection and sepsis test system, which produces three readouts that could help emergency physicians quickly determine the proper course of treatment.
Awak Technologies Pte Ltd. gained the U.S. FDA’s breakthrough designation for an artificial intelligence (AI)-based kidney disease progression prediction (KDDP) model on Nov. 27, following its $20 million fundraising that marked one of Singapore’s largest med-tech financings in 2023.
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