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ODAC Split On Avastin Use In First-Line Metastatic Breast Cancer
FDA's Oncologic Drugs Advisory Committee creates a second obstacle to the approval of Genentech's Avastin in metastatic breast cancer by deciding that existing data do not establish a positive risk-benefit profile for a first-line indication. Genentech's primary obstacle is relying on a surrogate endpoint for full approval, in trying to use progression-free survival as a direct measure of clinical benefit
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.
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US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.
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Reforming clinical trial regulations, addressing the use of artificial intelligence, mitigating medicines shortages and strengthening ties with other drug regulators are key priorities for Australia’s Therapeutic Goods Administration over the next year.