BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

TechBio company Cytomos (www.cytomos.com) today announces the launch of its much-anticipated flagship benchtop solution Celledonia™, which uses the company’s patented AuraCyt™ platform.

60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company” or “60 Degrees Pharmaceuticals”), a pharmaceutical company focused on developing new medicines for infectious diseases, announced today that the U.S. Food and Drug Administration (“FDA”) has granted its investigational tafenoquine candidate orphan drug designation for the treatment of patients with acute babesiosis.

Adverum Biotechnologies, Inc. announced the appointments of Dr. Rabia Gurses Ozden to the Company’s executive leadership team as chief medical officer and Dr. Szilárd Kiss to the Company’s Board of Directors.

Biora Therapeutics, Inc. announced that it will present preclinical data from the BioJet™ Systemic Oral Delivery Platform at the Next Gen Peptide Formulation & Delivery Summit, which will take place June 18–20, 2024 in Boston.

Annovis Bio Inc. announces that its recent Phase II/III Alzheimer’s study of its lead drug candidate, Buntanetap, showed statistically significant efficacy and safety in both carriers and non-carriers of Apolipoprotein E4, a genetic cause of AD.

NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”) today announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent No. 12,006,305, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof.”

Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA).

Charles River Laboratories International, Inc. announced a multidisciplinary program, funded through a $1.3 million grant from the Foundation for Chemistry Research & Initiatives, in coordination with the American Chemistry Council’s Long-Range Research Initiative, to develop a New Approach Methodology inhalation toxicology test to reduce reliance on traditional animal research methods.

Skyhawk Therapeutics, Inc. announced the promotion of Clint Musil, former Chief Financial Officer of Skyhawk Therapeutics, to Chief Executive Officer and the appointment of Bill Haney, former Chief Executive Officer and Co-founder of Skyhawk Therapeutics, to Executive Chairman of the Board of Directors.