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
Data show the vaccine regimen induced neutralising antibody responses in nearly all participating adults and children 21 days after the second dose. Adults receiving booster shots two years after the initial vaccination regimen showed strong immune responses
This clinical study demonstrated that the 14-day regimen of ImmunoSEB and ProbioSEB CSC3 resolved post-Covid-19 fatigue symptoms and improved patients' functional status and quality of life
The designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with a preserved ejection fraction
The medicine is now approved for eight indications across five different types of cancer in China.
Invega Hafyera offers patients the fewest doses per year. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months
Coordinated and collaborative efforts will strongly contribute to the achievement of shared goals faster: Mandaviya
Results reinforce the well-established safety profile of Dupixent - the first-ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old
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