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
MeMed BV is a first-of-its-kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes
The recipient is a 57-year-old woman who was suffering from severe biventricular heart failure and had undergone cardiac surgery several years ago
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
The country’s vaccine production has more than doubled since April and is set to touch 300 million doses next month
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
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
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
First participants enrolled in Phase 1 clinical trial of combination NanoFlu/NVX-CoV2373 vaccine with Matrix-M adjuvant. The Phase 1/2 study will also evaluate immunogenicity and safety
Hetero’s drug is a biosimilar version of Roche’s Actemra/RoActemra and will be available at the end of this month
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