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
Barbara Engelhardt moves her computational and statistics lab to Gladstone
The board has approved the settlement of US $ 248 million towards Direct Purchaser group and Retailer Opt-Out group subject to court approval
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
The document is a global recommendation for circular packaging design. It will be updated and adapted to changes in the collection, sorting and recycling technology, as well as to future material development
Packaged junk food which is a major component of unhealthy diets is responsible for more deaths worldwide than any other risk factor
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Results from these studies are expected to be released by 2023. If outcomes from these initial pilots are positive, the studies will be expanded to involve around 1 million participants in 2024 and 2025
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Visby Medical’s instrument-free PCR test to detect the SARS-CoV-2 virus can now be used to pool up to five patient samples using a single test
Laurus will be incentivised for a portion of its development and commercialisation costs. CHAI will also provide technical and regulatory support to enable accelerated generic development
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In several trials like Celestial (double-blind phase III trial), Phase III Meteor trials, Cabozantinib has shown better PFS (Progression-Free Survival).
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