Keyword: Food and Drug Administration (FDA)

News

FDA Grants EUAs to Omicron-targeted Covid Shots

02.09.2022 -

As had been widely expected, the US Food and Drug Administration (FDA) on Aug. 31 granted emergency use authorizations (EUAs) to the new Covid-19 shots developed by mRNA...

News

CSL Close to Finally Taking Control of Vifor

04.08.2022 -

Australian biopharma CSL said this week it has received all the regulatory clearance required to take over Switzerland’s Vifor. The acquisition announced in December 2021...

News

US Government Buys 3 Million Novavax Doses

13.07.2022 -

The US Department of Health and Human Services (HHS) and the Department of Defense (DOD) have ordered 3.2 million doses of Novavax’s Covid-19 vaccine, even before the...

News

FDA Panel Recommends Approval of Nuaxovid

09.06.2022 -

In a vote of 21 in favor with one abstention, the US Food and Drug Administration’s advisory panel has recommended that the FDA approve Novavax’s Covid-19 vaccine...

News

FDA Greenlights GSK’s MMR Vaccine

07.06.2022 -

The US Food and Drug Administration (FDA) has greenlit GSK’s Priorix-branded GSK’s mumps and rubella vaccine (MMR) for people 12 months and older. It is only the second...

News

FDA Restricts Use of J&J Covid Vaccine

13.05.2022 -

US health authorities are restricting the use of the Johnson & Johnson Covid vaccine somewhat belatedly, citing the rare blood clotting issues that have dogged this...

News

CDC and FDA Sideline Last Covid Antibody Treatment

07.04.2022 -

The US Centers for Disease Control and the Food and Drug Administration have removed the IV antibody treatment sotrovimab made by GlaxoSmithKline (GSK) and Vir...

News

FDA Panel Meeting to Discuss Covid Vaccine Boosters

22.03.2022 -

The US Food and Drug Administration has scheduled a virtual meeting of its scientific advisory panel for Apr. 6 to discuss the prospect of future Covid-19 boosters and...