Roche gets FDA priority review for Actemra/RoActemra to treat severe Covid-19
The US FDA has accepted the company’s supplemental Biologics License Application (sBLA) for tocilizumab and is expected to…
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05 Apr 22
The US FDA has accepted the company’s supplemental Biologics License Application (sBLA) for tocilizumab and is expected to…
04 Apr 22
The FDA approval is based on results from the Phase 3 ZUMA-7 study, evaluating the safety and efficacy…
01 Apr 22
The EC approval was supported by one-year data from the Phase 3 KESTREL and KITE studies, which evaluated…
31 Mar 22
Triumeq PD is a fixed-dose combination antiretroviral medication containing abacavir, dolutegravir and lamivudine, formulated as a dispersible tablet
30 Mar 22
The expanded authorisation allows the use of a second booster dose of Pfizer and BioNTech’s Covid-19 vaccine in…
30 Mar 22
The expanded indication for the HIV regimen provides a treatment option for virologically suppressed young people living with…
29 Mar 22
Fintepla oral solution was originally developed by Zogenix, which was acquired by UCB in a transaction worth around…
29 Mar 22
The Japanese regulator’s approval was based on results from global Phase 3 HELP study, Phase 3 HELP OLE…
25 Mar 22
The breakthrough designation is based on the positive results from a proof-of-concept, Phase 2a study in healthy adults…
25 Mar 22
The EMA recommendation is based on the Phase 3 PROVENT trial, in which Evusheld significantly reduced the risk…