infectiousdiseaseadvisor.com15h
Twice-Yearly Lenacapavir Gets Priority Review For HIV PrEP
The FDA has accepted under Priority Review the NDA for lenacapavir for the prevention of HIV as pre-exposure prophylaxis.
Pharmaceutical Technology on MSN6d
Gilead’s lenacapavir applications for HIV gain EMA validation
Gilead Sciences has announced EMA validation for a parallel accelerated review of lenacapavir’s MAA and EU-M4all applications ...
Gilead Sciences sets aside $200 million to resolve HIV drug probe
Gilead Sciences set aside $200 million for a potential settlement with federal prosecutors to resolve an investigation into ...
Rolling Out4d
HIV breakthrough faces critical funding cuts
A revolutionary advancement in HIV prevention technology stands at a critical crossroads as recent policy decisions threaten ...
Yahoo Finance6d
Gilead’s lenacapavir applications for HIV gain EMA validation
Gilead Sciences has announced the European Medicines Agency’s (EMA) validation for a parallel accelerated review of lenacapavir’s marketing authorisation application (MAA) and EU-Medicines for ...
Trump’s Funding Cuts Halt Rollout Of HIV Prevention Drug
A groundbreaking injectable designed to curb the global spread of HIV is now at risk of being delayed due to Donald Trump's ...
Yahoo Finance6d
Morgan Stanley sees FDA approval of GILD's Lenacapavir
Investing.com -- Morgan Stanley expects the FDA to approve Gilead Sciences (NASDAQ:GILD)' Lenacapavir (LEN) for HIV prevention (PrEP) on or before its June 19 PDUFA date, a move that the bank ...
Pharmabiz6d
EMA validates Gilead’s MAA and EU-Medicines for all application for twice-yearly lenacapavir for HIV prevention
Foster City, California Tuesday, February 25, 2025, 16:00 Hrs [IST] ...
Morgan Stanley sees FDA approval of GILD's Lenacapavir
Investing.com -- Morgan Stanley expects the FDA to approve Gilead Sciences (NASDAQ: GILD )' Lenacapavir (LEN) for HIV ...