Food and Drug Administration (FDA)
NEWS
Although the data suggests the vaccines are extremely effective and generally safe, analysis is still coming in about adverse events as well as effectiveness in specific patient populations.
The U.S. FDA placed a partial hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program in the U.S.
It’s a promising day for advanced ovarian cancer research as two biopharma companies achieved positive results. Here’s what you need to know about research.
In a meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, six members voted not to approve the NDA for Amylyx’s ALS candidate, AMX0035, while four voted in favor.
The FDA has rejected Cambridge, Mass.-based Akebia Therapeutics’ New D2rug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.
Lately, there has been heightened attention to briefing documents in the CNS space, a notoriously tricky area to get drugs approved, which can affect company stock prices.
A new study shows that a second COVID booster is highly effective in preventing death in older adults.
JOBS
IN THE PRESS