The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no longer be justified, the FDA said. The terminated panel’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee.

Bristol’s CEO offered assurances about Medicare negotiations under the IRA as the company delivered better-than-expected second quarter results across new and legacy products.

The EMA says the benefits of treatment with Leqembi are not large enough to outweigh its risks. Meanwhile, Alzheimer Europe is hoping that real-world findings from the US-mandated patient registry or from ongoing trials will help persuade the EU regulator to reconsider its position.

Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.