Phase II
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.
Redosing is a large and growing concern for gene therapy developers and regulators.
Calithera Biosciences is expanding its oncology portfolio with the addition of two clinical-stage compounds from Takeda Pharmaceuticals.
AT-527, an oral direct-acting antiviral agent that blocks viral RNA polymerase needed for viral replication, failed to meet its primary endpoint in the Phase II MOONSONG study.
On Monday, LogicBio Therapeutics unveiled clinical trial results demonstrating the first-ever in vivo, nuclease-free genome editing in little humans.
The U.S. FDA greenlit a new indication for Gilead Sciences’ drug Biktarvy for pediatric patients with HIV who are virologically suppressed or new to antiretroviral therapy.
Vertex Pharmaceuticals announced positive Day 90 data from the first patient in its Phase I/II study of VX-880 in type 1 diabetes.
Cartesian’s Descartes-08 is a new chimeric antigen receptor (CAR) - T cell therapy that strives to target the myasthenia gravis disease at its source.
It was yet another busy week for clinical trial announcements. Take a look.
The news of a unanimous decision by the adcom came just two days after the agency issued a 45-page document that contained vague comments on the drug.
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