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Shares of Bicycle Therapeutics plc (BCYC) are up 9% on Monday after the company announced that it will proceed with its plan to expedite the development of BT8009 for metastatic bladder cancer.
2022 was a big year for the pharmaceutical and biotechnology sectors. Novel technologies emerged at a rapid clip. The Food and Drug Administration (“FDA” or the “Agency”) approved over...
The US Food and Drug Administration is working with pharma to reform the accelerated approval process, introduce novel drugs to earlier therapy lines, and make trials more accessible.