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An FDA advisory committee recommended 14-1 yesterday that the FDA withdraw accelerated approval for Covis Pharma’s preterm birth drug Makena. Read More
The FDA has updated two compliance program guidances that provide instructions for agency staff conducting inspections, adding provisions for use of alternative inspection tools as well as bringing them into closer alignment with International Council for Harmonization (ICH) quality guidelines. Read More
The FDA has postponed its decision date on Travere Therapeutics’ new drug application (NDA) for sparsentan by three months, pending an update of the drug’s risk evaluation and mitigation strategies (REMS) plan. Read More
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