The Latest Breaking News from FDA

By David Bautz, PhD NASDAQ:BCLI READ THE FULL BCLI RESEARCH REPORT

The FDA has granted priority review to Roche Holdings AG's (OTC:RHHBY) Actemra/RoActemra (tocilizumab) for COVID-19 in hospitalized adults. "If approved, Actemra/RoActemra would be the first U.S. FDA-approved immunomodulator for treating COVID-19 in hospitalized patients," Roche said. The Compay also added that more than 1 million people hospitalized with COVID-19 had been treated with Actemra/RoActemra…

Long gone is the heyday of investor enthusiasm and easy access to capital that marked the launch of the psychedelics industry into the public markets. In recent months, psychedelics stocks entered into a period of turmoil characterized by declining valuations and a generalized capital dry spell.

At the American College of Cardiology, Lexicon Pharmaceuticals Inc (NASDAQ:LXRX) highlighted a new data analysis from the SCORED Phase 3 trial of sotagliflozin in Type 2 diabetes and kidney disease patients. Sotagliflozin significantly reduced major adverse cardiovascular events (MACE) of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke compared to placebo. Also See: Lexicon Announces…

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Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.

Regulators have long targeted tobacco products, but there's new energy behind outright bans on vapes and cigarettes.

Biopharma stocks are sensitive to a key binary event called the PDUFA date, the date by which the Food and Drug Administration is required to give its verdict on a regulatory application filed with it.

Just three Republicans voted for the MORE Act, two fewer than in 2020.