EMA Considers Adolescent Booster-Dose Application for Comirnaty
EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.
The European Medicines Agency (EMA) has started its evaluation of an application for the use of a booster dose of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, in adolescents aged 12–15 years.
As reported in a Feb. 8, 2022 press release, EMA’s Committee for Medicinal Products for Human Use (CHMP) will perform an accelerated assessment of data that has been submitted by the company responsible for marketing Comirnaty. The data that has been submitted includes real-world evidence from Israel.
Currently, the booster doses of Comirnaty are approved to be administered in patients aged 18 years and older. An application for a booster dose of the vaccines in patients aged 16–17 years is also ongoing.
EMA will provide further information and updates on the evaluation in due course.
Source: EMA
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.
