Managed Healthcare Executive4h
FDA Approves NDA for Gilead's new HIV Prevention Shot
Lenacapavir is a twice-yearly injectable medication designed to be used as pre-exposure prophylaxis (PrEP). The FDA is giving ...
FiercePharma8h
Bavarian Nordic catches up to rival Valneva with broad chikungunya vaccine approval from FDA
Two years on, Bavarian Nordic’s $380 million vaccine M&A move appears to be paying off. | Valneva may have won the ...
GlobalData on MSN9h
Gilead’s lenacapavir moves closer to FDA approval for HIV PrEP use
The US Food and Drug Administration (FDA) has accepted Gilead’s new drug application (NDA) for lenacapavir and set a prescription drug user fee act (PDUFA) target action date of ...
Gilead Gets FDA Priority Review of Twice-Yearly Shot to Prevent HIV
Gilead Sciences has won Food and Drug Administration priority review for its proposed lenacapavir twice-yearly shot to prevent HIV. Gilead on Tuesday said an FDA green light would make lenacapavir the ...
Chimerix’s NDA for dordaviprone accepted by FDA
Chimerix (CMRX) announced the FDA has accepted its New Drug Application, or NDA, seeking accelerated approval for dordaviprone as a treatment ...