Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
The RRA was conducted from 22nd August, 2022 to 26th August, 2022.
Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age
With the receipt of the EIR, the inspection stands successfully closed.
Lutio has the potential to offer significant cost savings when available to UK patients.
This Bioforum will provide the latest insights on delivering increased speed, greater flexibility and enhanced quality while reducing the cost, and risks of navigating the evolving biopharma landscape
The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
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