Novavax on Thursday tried to calm investors spooked by the delay of full approval of its COVID vaccine shot by U.S.

FDAは、追加接種の有効性に関するデータが不十分であることと、ワクチン接種の推奨に対する国民の信頼が低下していることを理由に、来シーズンのCOVID-19ワクチンの承認に対するアプローチを再検討している。 FDA長官のマーティ・マカリー博士は、新たな ...

Vinay Prasad, named to lead the FDA agency tasked with regulating vaccines and gene therapy, has made controversial comments ...

A new vaccine that combines flu and COVID-19 protection in one shot shows promising results, but the U.S. Food and Drug ...

The independent experts will meet on May 22 to discuss updates to the COVID-19 vaccine for the upcoming season.

25日の米株式市場で米バイオテクノロジー企業 ノババックス の株価が下落。同社の新型コロナウイルスワクチンについて米規制当局から新たな臨床試験の実施を求められたと、米紙ウォールストリート・ジャーナル（ＷＳＪ）が同日報じた。

The head of the U.S. Food and Drug Administration on Tuesday reportedly raised doubts about the need for COVID booster shots ...

Novavax said on Thursday discussions with the U.S. health regulator on its COVID-19 shot are ongoing and a pathway to ...

The U.S. Food and Drug Administration said on Wednesday it will hold a meeting of experts on May 22 to discuss COVID-19 ...

In his new role with the FDA, Dr. Vinay Prasad will oversee the regulation of costly drugs, including vaccines, gene ...

Senior leaders at the FDA began pushing Moderna and Pfizer to file for full, formal approval of their COVID vaccines for ...