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
Surufatinib is the third potential new medicine discovered by the company to enter into clinical development in Japan
In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralising antibody responses. Results in children under 5 years of age are expected as soon as later this year
New Gibco AAV-MAX Helper Free AAV Production System helps reduce production costs and streamline the transition from research to clinical environments
The CASPIAN Phase III trial in extensive-stage small-cell lung cancer is the longest survival follow-up ever reported for immunotherapy treatment in this setting
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
This procedure is incidentally the first robotic bariatric surgery in the world to be performed in just three ports
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
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