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Telesta Therapeutics has received a complete response letter from the FDA, informing the company that its BLA for Mycobacterium phlei cell wall-nucleic acid complex would need an additional Phase 3 clinical trial to adequately establish the candidate’s efficacy and safety. Read More
The EMA’s Committee for Medicinal Products for Human Use has recommended six new medicines for marketing authorization, including three innovators and three generics. Read More
The UK’s reimbursement watchdog has given its blessing to five treatments — four for cancer and one for a lung disease — recommending they be funded by the National Health Service, while frowning on Lilly’s stomach cancer drug. Read More