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Ublituximab — TG Therapeutics’ potential blockbuster infusion for multiple sclerosis (MS) — is probably more clinically effective than the approved oral disease-modifying therapies but wouldn’t be cost-effective if priced the same as Roche’s Ocrevus at $55,081 per year. Read More
In a trio of guidances released Monday, the FDA laid out new recommendations for research on cancer drugs, including how to develop drugs for acute myeloid leukemia (AML), how to classify the side effects of immunotherapies and best practices for developing therapies targeting biomarkers across multiple cancer types. Read More
A failure to withdraw marketing approval of Covis’ preterm birth drug Makena would amount to a failure of FDA’s Accelerated Approval pathway, according to Peter Stein, director of the agency’s Office of New Drugs. Read More
The U.S. Department of Justice (DOJ) announced that three members of a Miami-based research center have been charged for allegedly running a years-long scheme to falsify clinical trial data for profit. Read More
In the wake of the reauthorization of the Generic Drug User Fee Amendments (GDUFA), the FDA has updated its guidance for prior approval supplements (PAS) and amendments for abbreviated new drug applications (ANDA) under GDUFA III. Read More
The Department of Health and Human Services (HHS) will have to come up with a plan to force down the cost of prescription drugs under an executive order signed by President Biden on Friday. Read More