Pasithea Therapeutics Corp. has received written responses from the FDA to questions submitted for a type 2 pre-IND meeting regarding the clinical development plan for PAS-004 (CIP-137401).
Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.
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.
“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.
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.
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.
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.
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