Drug Approval | September 21, 2021
U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
The recipient is a 57-year-old woman who was suffering from severe biventricular heart failure and had undergone cardiac surgery several years ago
With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) setting
The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy
If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC
Initiation of EBT-101 Phase 1/2 clinical trial expected later this year
The clinical trial, to be conducted in two phases, will evaluate the safety and efficacy of Mesocel for the treatment of patients with moderate to severe Covid-19
They enter into exclusive negotiations in a new drive to create a technology-driven leader for complex small molecules and ADCs of global scale
BB will have access to 100 million doses of vaccines annually and commercialization rights of the SILS vaccine portfolio for global markets
Barbara Engelhardt moves her computational and statistics lab to Gladstone
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