13 August 2024
13 August 2024
The company plans to ask the US FDA to reconsider its request for an additional Phase III trial for the approval of Lykos鈥� MDMA capsules for PTSD.
Abrysvo was found to be safe in immunocompromised adults at risk for developing RSV-associated lower respiratory tract disease.
As Regeneron and Bayer fend off competition for Eylea copycats in the courts, Sandoz says Enzeevu will be a 鈥渒ey biosimilar value driver鈥�.
Seizures in a patient with KIF1A-associated neurological disorder (KAND) fell from 100-290 a day to under 30 per week after treatment.
Citius Oncology鈥檚 asset LYMPHIR has gained FDA approval for CTCL treatment in adults.
The company expects initial supply of the product in the first quarter of 2024.
In a Phase III trial, patients treated with toripalimab experienced a significant prolongation of PFS versus dacarbazine.
The approval is grounded in the positive outcomes from the Phase III OLYMPIA clinical trials.
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