Rheumatology Advisor3h
FDA Approves Freeze-Dried Formulation of Mpox, Smallpox Vaccine
The FDA has approved a new freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating).
The Pharma Letter7h
Research shows need for better mpox protection in HIV-positive patients
A new report from GlobalData has raised concerns over the effectiveness of mpox vaccines for people living with HIV. Findings ...
MedCity News1d
Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions
As the FDA’s top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and mass layoffs throughout the FDA raise concerns about the agency’s ability to ...
CIDRAP2d
HHS begins layoffs, reassignments, including NIAID director
Jynneos was the first smallpox vaccine developed under Project BioShield, a program created by Congress in 2004 to accelerate ...
CIDRAP2d
FDA approves freeze-dried version of Jynneos mpox vaccine
Yesterday the US Food and Drug Administration (FDA) approved a freeze-dried formulation of Bavarian Nordic's mpox vaccine, ...
Bavarian Nordic’s Jynneos highlights unmet need for mpox prevention in HIV patients
This recent safety and effectiveness data regarding mpox vaccination with Jynneos is important and timely given the ongoing ...
FDA approves Bavarian Nordic’s freeze-dried mpox and smallpox vaccine
The formulation allows for greater stockpiling, with Bavarian Nordic already working with the US Government to add to vaccine ...
US FDA approves freeze-dried version of Bavarian Nordic's mpox, smallpox vaccine
Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
Bavarian Nordic Receives U.S. FDA Approval of Freeze-Dried Smallpox and Mpox Vaccine
The Company has been contracted by the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of JYNNEOS for stockpiling. Manufacturing under ...