BioSpace News Archive

Anumana, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure.

Pharmazz, Inc. (“Pharmazz” or the “Company”) announced that it has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the study design and statistical analysis plan of its Phase 3 clinical trial of Sovateltide (Tycamzzi™) for the treatment of acute cerebral ischemic stroke patients.

Repligen Corporation today announced that it has appointed 20+ year industry veteran Olivier Loeillot to the newly created position of President and Chief Commercial Officer (CCO), effective immediately.

Zevra Therapeutics, Inc. announced interim data from the open-label dose titration phase of the Phase 2 clinical trial evaluating KP1077 in patients with idiopathic hypersomnia (IH).

TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of data presentations, highlighting data from both the ULTIMATE I & II Phase 3 trials and the ENHANCE Phase 3b trial evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the upcoming 2023 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, being held October 11 – 13, 2023, in Milan, Italy.

Apyx ® Medical Corporation today announced that financial results for the third quarter of fiscal year 2023 will be released before the market opens on Thursday, November 9th.

Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea and related disorders, announced the appointment of Paul Fonteyne, MS, MBA, to its Board of Directors as an Independent Director.

NovaBay Pharmaceuticals, Inc. announces that Justin Hall, CEO and General Counsel, will present a company overview and hold investor meetings at the 8th Annual Dawson James Small Cap Growth Conference being held Thursday, October 12, 2023 at the Wyndham Grand Harborside Hotel in Jupiter, Fla.

Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced eight data presentations (from an Attralus sponsored trial and from four investigator-initiated trials) related to the use of 124I-evuzamitide (AT-01), the company’s pan-amyloid binding imaging agent in development for the diagnosis and management of all types of systemic amyloidosis.

Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the U.S. Food and Drug Administration (FDA) has approved the EMPAVELI® Injector.