Vaccines Advisory Committee to Meet on October 22
Hahn promises transparency in the review and approval of COVID-19 vaccines.
FDA announced the agency will hold a public meeting of the Vaccines and Related Biological Products Advisory Committee on Oct. 22, 2020 to discuss the development, authorization, and/or licensure of COVID-19 vaccines. The meeting is scheduled from 10 am–5 pm ET via webcast.
“The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee to address the general development of COVID-19 vaccines on October 22nd. The agency is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said FDA Commissioner Stephen M. Hahn, in an Aug. 28, 2020 statement. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible. A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent COVID-19 and the data needed to facilitate their authorization or licensure. It is critical for people to see FDA’s expectations for data to support safety and effectiveness.”
Source: FDA
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
