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A federal judge ruled earlier this week that stem cell therapies are procedures, not drugs, and that the FDA has no jurisdiction over them, blocking the agency’s attempt to regulate the California Stem Cell Treatment Center’s (CSCTC) products. 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
Novo Nordisk’s Wegovy (semaglutide) was superior when compared to several other weight loss drugs for therapeutic effect, but at an annual cost of $7,500 to $9,800 would require a discount from the wholesale acquisition cost of 44 to 57 percent to make it cost effective. Read More