The Latest Breaking News from FDA

Veterinarian Dr Lynn Happel is urging owners to wash their dog's toys at least once a month to avoid them from picking up an illness from 'respiratory corona virus or a micro-plasma bacteria'

Cue Biopharma, Inc. (NASDAQ: CUE) received the U.S. Food and Drug Administration (FDA) acceptance of the Investigational New Drug (IND) application for the evaluation of CUE-102 in the treatment of Wilms' Tumor 1 (WT1)-positive recurrent/metastatic cancers.

In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients. The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for…

Along with much of the globe, US consumers are reeling from a cost of living and supply-chain crisis. One example is a shortage of baby formula caused by a constellation of factors, from rampant inflation to a massive recall over safety concerns.

The FDA approved Eli Lilly And Co's (NYSE:LLY) Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).  Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.  The FDA first issued an emergency use authorization (EUA) for Olumiant combined with remdesivir to treat…

Fast-track drug approval process marked for limited changes

OAKLAND, Calif. — Dr. Andrew Herring has a clear goal walking into every appointment with patients seeking medication to treat an opioid use disorder: persuade them to get an injection of extended-release buprenorphine.

The shortage has intensified in recent weeks due to supply chain issues and a devastating recall.

The U.S.