The U.S. Food and Drug Administration authorized the use of an additional batch of Johnson & Johnson’s one-dose Covid-19 vaccine manufactured at the problem-plagued Baltimore factory of Emergent BioSolutions Inc.

The U.S. Food and Drug Administration requested that Emergent BioSolutions temporarily pause production of ingredients for the Johnson & Johnson Covid-19 vaccine at their facility in Baltimore.

Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.

The cancer drugmaker pled guilty of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to investigators in federal court. 

GlaxoSmithKline discontinued a Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody aimed at treating ulcerative colitis licensed from Australia-based Immutep Limited following an interim assessment of an Independent Data Monitoring Committee.

Spectrum Pharmaceuticals announced that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration can approve the company’s Biologics License Application for Rolontis (eflapegrastim).

Akorn Inc. received a warning letter from the U.S. Food and Drug Administration following an inspection of the generic drugmaker’s Decatur, Illinois manufacturing plant during 2018.

PALO Alto, Calif. – More questions have arisen about the leadership structure at Theranos, following a Forbes column questioning decisions over stock splits and how much of a say shareholders in the private company have regarding company direction. Forbes columnist Peter Cohan cites a 2013 letter to shareholders asking support for the creation of two […]