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 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
It will also manage test result documentation for employees who are not vaccinated, sending weekly reminders and employer notification
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
These were the findings of the Post Marketing Surveillance (PMS), study of Favipiravir (FabiFlu) on over 1000 patients
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
Research collaboration covers multiple antibody research programs
One batch has 11.4 million units of Naproxen tablets out of which 0.9 million units that were released into the market were recalled
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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