Agency issues Emergency Use Authorization for hydroxychloroquine sulfate, along with a novel COVID-19 test.
Clinical trial results were similar to those of the drug in adults.
First point-of-care test to detect coronavirus cleared.
The agency takes other steps to make COVID-19 tests more available.
New measures taken due to depression, suicidal thoughts, and other adverse events.
Discover the latest news on COVID-19 vaccine and drug development.
Companies cited over false coronavirus claims include The Jim Bakker Show.
Isatuximab-irfc (Sarclisa, Sanofi-Aventis) was approved in combination with pomalidomide and dexamethason to treat adult patients with multiple myeloma who have received at least two prior therapies.
Inhaler is the first generic approval of its kind.
Treatment is first non-statin LDL-C lowering treatment approved in years.