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
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
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
The net proceeds from the issue will be utilised towards the purchase of machinery, modernising existing units and expansion of its R&D facilities
Self-collection devices designed for ease of use and safety
Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
InferVision's AI applications have been developed to quickly and accurately analyse signs of pulmonary infections from regular chest CT images. These images are processed to indicate ground-glass opacity and high tissue density, which are key findings of viral pneumonia caused by the coronavirus
Deal for 100 million doses with additional 100 million through 2023
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