FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.
FDA issued an emergency use authorization to ACON Laboratories Flowflex COVID-19 Home Test, an over the counter COVID-19 antigen test, on Oct. 4th, 2021. According to a press release from the organization, this was done to increase rapid testing accessibility for the general public in the United States.
According to an FDA press release, the authorization of the new antigen test will double rapid at-home testing capacity in the US over the next several weeks. ACON plans to produce more than 100 million tests per month by the end of the year and will begin making 200 million per month by February 2022.
FDA has authorized more than 400 COVID-19 tests and sample collection devices, but most antigen tests for at-home use are authorized for serial testing or testing the same individual more than once within a few days. As a result of data provided concerning asymptomatic individuals, the ACON test does not require serial testing.
“We believe at-home diagnostic tests play a critical role in the fight against COVID-19,” FDA said in the press release. “We will continue to offer support and expertise to help with the development of appropriately accurate and reliable tests, and to facilitate increased access to tests for all Americans.”
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.
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.
2 Commerce Drive
Cranbury, NJ 08512