Tags : approval

Regulatory

Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) Low-Dose Tablet Receives the US FDA’s

Shots: The approval is based on cohort 3 of a P-II/III study that evaluates Biktarvy (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in 22 Pediatric patients with HIV-1 who are virologically suppressed or new to antiretroviral therapy The results showed that Biktarvy low-dose tablets were found to be effective & well-tolerated @24wks. After switching to Biktarvy, 91% […]Read More

Biosimilars Regulatory

Boehringer Ingelheim’s Cyltezo (biosimilar, adalimumab) Receives the US FDA’s sBLA

Shots: The approval is based on the P-III VOLTAIRE-X trial evaluates the effects of multiple switches b/w Humira and Cyltezo in patients with multiple chronic inflammatory diseases The study showed that Cyltezo was equivalent to Humira & demonstrated that switching several times b/w Cyltezo and Humira resulted in no clinical differences in PK, efficacy, immunogenicity, […]Read More

Regulatory

ViiV Healthcare Submits Regulatory Applications to the US FDA for

Shots: ViiV Healthcare has reported a regulatory submission to the US FDA for the approval of a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir & lamivudine. The submission is based on modeled data and in line with regulatory recommendations The company expands its approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower […]Read More