The Latest Breaking News from FDA

A new peer-reviewed study compared the effects of LSD and psilocybin, two substances currently standing as top molecules behind the recent psychedelic medicine boom. While both compounds have a rich history of human use, not much research has been dedicated to contrasting the effects they produce in human psychology. The…

Parents who bought recalled infant formulas made by Abbott Laboratories are filing proposed class-action lawsuits against Abbott, as the U.S. Food and Drug Administration investigates reports of three babies who became sick and two who died after consuming the formulas.

About 80% of parents confirmed they know little to nothing about CBD use in children, according to a recent poll by the Universit

Sensus Healthcare Inc (NASDAQ:SRTS) sold its Sculptura assets to Empyrean Medical Systems for $15 million in cash.  The sale included an inventory of Sculptura systems and parts, in addition to all related intellectual property. The Sculptura system provides targeted Directional Anisotropic Radiation Therapy (ART) and brachytherapy utilizing proprietary, state-of-the-art 3D Beam Sculpting to treat…

The FDA has issued a clinical hold on Celyad Oncology SA's (NASDAQ:CYAD) CYAD-101-002 (KEYNOTE-B79) Phase 1b trial due to insufficient information to assess risk to study subjects. As previously disclosed, the Company announced that it was voluntarily pausing the CYAD-101-002 trial to investigate reports of two fatalities in the study. Celyad Oncology is a clinical-stage biotechnology…

The FDA has issued a clinical hold letter to Finch Therapeutics Group Inc's (NASDAQ:FNCH) PRISM4 Phase 3 trial of CP101 in recurrent C. difficile infection (CDI). The Company has paused enrollment in the trial as the FDA has asked for additional information about Finch's SARS-CoV-2 donor screening protocols. The FDA placed Finch's investigational new…

Here's a roundup of top developments in the biotech space over the last 24 hours.

The Food and Drug Administration approval calendar was light in February. Nevertheless, the month saw regulatory nods accorded to some breakthrough therapies.

There are three COVID-19 tests distributed in the U.S. to avoid and if you already have any of them, don’t use them, the Food and Drug Administration is warning of the unauthorized tests.

Key takeaways: GenScript Biotech said it lost up to $519 million last year, with its Legend Biotech unit accounting for nearly 70% of that Legend Biotech’s Cilta-cel CAR-T cell therapy product was approved by the FDA on Monday, and could become a major cash cow for GenScript Biotech By Molly…

The FDA has issued a complete response letter (CRL) for Gilead Sciences Inc's (NASDAQ:GILD) application for lenacapavir for heavily treated multi-drug resistant (MDR) HIV-1 infection. Lenacapavir is an investigational, long-acting HIV-1 capsid inhibitor. In the CRL, the FDA has cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir with the…