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…
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. Source: Drug Industry Daily
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. Source: Drug…
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…
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…
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…
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. Source: Drug Industry…
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…
In the midst of a pandemic, if you wait for all the data to come in, “you’ve missed the boat,” said FDA Commissioner Robert Califf yesterday regarding the agency authorizing…
Inadequate procedures to minimize the risk of contamination earned Lupin Limited a Form 483 following a March 22 to April 4 FDA inspection of its facility in Palghar, Maharashtra, India.…