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After an FDA career that has spanned more than three decades, former FDA Acting Commissioner Janet Woodcock — who now serves as principal deputy commissioner — still plays a significant role in guiding the agency. Read More
The complaint alleges that the deal between the companies says that if the risk reduction in the Nexletol trial was 20 percent or better, Daiichi would pay Esperion $300 million. Read More
The forum will consider the impact of potential treatments by “refining existing measurement tools that clinical research has shown may not always adequately assess a drug’s effectiveness,” the FDA says. Read More
Despite the approaching end of the COVID-19 public health emergency (PHE) in the U.S., medical products approved under emergency use authorizations (EUA) will remain available for the foreseeable future, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), in the New England Journal of Medicine (NEJM) Thursday. Read More
The government needs to step in and regulate the rebates that pharmacy benefit managers (PBMs) extract from drug companies and Medicare needs to do a better job of policing the prices in PBMs’ Part D bids, said experts who testified at a House Finance Committee hearing Thursday. Read More
As part of its efforts to harmonize with international standards for exchange of medicinal product data, the FDA has issued a final guidance on the use of five International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. Read More
A federal court has ruled the FDA must share with Vanda Pharmaceutical its internal deliberation notes on why it denied Vanda’s supplemental new drug application (sNDA) for its sleep-disorder drug Hetlioz (tasimelteon) for jet lag. Read More
GOTHENBURG, SWEDEN — The approval of two Alzheimer’s disease-modifying therapies is giving the field a much-needed shot in the arm, experts said during a panel discussion at the Alzheimer’s and Parkinson’s Disease 2023 meeting. Read More