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
With the MONALEESA-2 final analysis, only Kisqali has reported statistically significant overall survival (OS) benefit with an aromatase inhibitor for postmenopausal women with HR+/HER2- advanced breast cancer in the first-line (1L) 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
It approves tissue-based NGS companion diagnostic for Takeda's targeted therapy for NSCLC patients with EGFR Exon20 insertion mutations
Zydus was the first to file an ANDA for Tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength
XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor
India’s dependency on China for pharma intermediates can change if there is a proper coordination between educational institutes, research institutes and pharma manufacturers
CDSCO to fast-track trials and approval for COVID19 vaccine
Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors
It is expected that the drug substance would be available from August 2021 which will be supplied back to Bharat Biotech for producing COVAXIN
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