Actelion Pharmaceuticals Ltd.
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Latest From Actelion Pharmaceuticals Ltd.
US FDA Bids Adieu To Allergenic Products Adcomm; Vaccines Panel To Take Over Duties
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.
PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion
But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.
BMS ‘Increasingly Confident’ It Can Handle The Impact Of Medicare Pricing For Eliquis
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.
New Drugs For Gastric Cancer, Liver Disease Among 14 Products Heading For EU Approval
Two orphan drugs are among a host of products that the European Medicines Agency’s human medicines committee has OKd for pan-EU approval.
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