Food and Drug Administration (FDA)
NEWS
Amylyx Pharmaceuticals shared news that the FDA has extended the review period for AMX0035, a combination drug treatment with the potential to treat patients with ALS.
The FDA has expressed worries over four cases of heart inflammation, or myocarditis, that were observed in pivotal clinical trials of Novavax’s COVID-19 vaccine.
Acelyrin, Affibody AB and Inmagene Biopharmaceuticals presented positive Phase II data for izokibep in psoriatic arthritis, while Aurinia’s Lupkynis hit post-hoc treatment targets in lupus nephritis.
The FDA requested more data on effectiveness, particularly evidence that shows plasma arginine and metabolic reduction can predict clinical benefit in patients living with ARG1-D.
Bristol Myers Squibb’s Orencia and Johnson & Johnson’s Remicade improved survival rates for people hospitalized with COVID-19 according to a new report by the National Institutes of Health.
Monkeypox is not COVID-19, but both are viral diseases that are front-and-center in the world of public health and epidemiology. Here’s a look at the latest news on both outbreaks.
Regeneron Pharmaceuticals announced intentions to acquire Sanofi’s stake in a drug they developed together, Libtayo (cemiplimab).
Children under the age of five could be eligible to receive Pfizer-BioNTech’s vaccine against COVID-19 as soon as late June.
Shares of TG Therapeutics are falling fast in Wednesday trading after the U.S. Food and Drug Administration announced it was pulling approval of the cancer drug Ukoniq (umbralisib).
JOBS
IN THE PRESS