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
The investment programme is expected to significantly reduce commercialisation lead times, costs and introduce more sustainable manufacturing processes
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
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The council has also reduced the GST to 5 per cent on a few more Covid-19 medicines
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
Study to explore heterologous regimen of COVID-19 vaccines from different manufacturers in adolescents 12-16 years of age
Between 30-40 per cent of Covid-19 patients are either obese or diabetic
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