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The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More
In a May 6 briefing before Congress, the director of the FDA’s Center of Biologics Evaluation and Research (CBER), Peter Marks, said the agency would not withhold authorization for a pediatric vaccine solely because it did not reach a 50 percent efficacy threshold at blocking symptomatic infection — a requirement that had been previously listed in FDA guidance. Read More
Citing the risk of rare blood clots, the FDA announced late yesterday that it is limiting the Emergency Use Authorization (EUA) for the Johnson & Johnson/Janssen COVID-19 vaccine to certain individuals. Read More
One day after Pfizer CEO Albert Bourla said physicians could prescribe a second course of the company’s oral COVID-19 treatment Paxlovid to patients who suffer a rebound, the FDA refuted the executive’s statement. Read More
A decision on the composition of a COVID-19 vaccine to be administered to the American population beginning this fall will need to be made by June. Read More