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Novo Nordisk is beefing up its hematologic portfolio with the $1.1 billion acquisition of Forma Therapeutics, snagging the company’s late-stage sickle cell anemia candidate etavopivat. Read More
The FDA conducted 113 pre-abbreviated new drug application (ANDA) meetings in support of the development of generic drug products in fiscal 2021, up from 92 in fiscal 2020. Read More
Florida governor Ron DeSantis (R) is suing the FDA for “unlawfully withheld or unreasonably delayed” approval of a program that would permit the state to import prescription drugs from Canada to save residents a purported $150 million a year. Read More
The FDA has denied a request by Intarcia for a hearing on its New Drug Application (NDA) for the company’s investigational drug-device product ITCA 650 (exenatide) for treatment of type 2 diabetes. Read More
NICE said the clinical trial evidence showed that the transplants are significantly better than antibiotics alone in resolving C. diff infections in the recommended patient population. Read More
The FDA has issued a warning letter to Green Wave Analytical for denying the agency’s investigators access to the contract testing laboratory’s San Diego, Calif., facility for the first three days of its inspection and for inadequate testing methods and record-keeping failures. Read More
Amgen’s oral chemotherapy sotorasib significantly improved progression-free survival relative to intravenous docetaxel in patients with previously treated KRAS G12C-mutated nonsmall-cell lung cancer (NSCLC) in a late-stage study. Read More