Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.
The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.
Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
The agreement extends the customer's suite of cloud DevOps, data engineering, and data platform management solutions
OncoVeryx-F, a proprietary test developed by PredOmix, is set to transform early-stage cancer detection
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
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