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
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
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
Initiation of EBT-101 Phase 1/2 clinical trial expected later this year
Klifovet’s client base comprises the world’s top animal health and nutrition companies as well as many promising startups
Between 30-40 per cent of Covid-19 patients are either obese or diabetic
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
Everest gains access to a clinically validated mRNA platform and a potentially “best-in-class” mRNA COVID-19 vaccine with full technology transfer
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
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
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