The FDA has refused to review Theratechnologies’ supplemental Biologics License Application, seeking approval for an intramuscular formulation for the maintenance dose of its HIV therapy Trogarzo (ibalizumab-uiyk), the biotech announced on Tuesday.
Tag Archive for: HIV drug
Gilead Sciences is headed to trial in Delaware federal court this week to fight claims that it owes the U.S. government a share of multibillion-dollar profits from its HIV-prevention drug regimen.
GSK began 2023 with a quarterly performance that beat analyst expectations and extended a series of positive results thanks to strong sales of its vaccines as well as HIV and respiratory medicines.
A federal judge in New York has frozen the assets of dozens of people and entities accused of operating a massive nationwide scheme to distribute counterfeit bottles of Gilead Sciences Inc. HIV drugs, including two alleged “kingpins.”
The company stated that it would start fresh late-stage studies of its HIV treatment, islatravir, months after the U.S. Food and Drug Administration put the trials on hold, citing safety concerns.
