Genentech has resumed development of Xolair following the lifting of a clinical hold, VP-Medical Affairs Stephen Dilly, MD, said at the Robertson Stephens Medical Conference in New York Nov. 29. "We addressed the questions that FDA posed...and now the clinical hold has been lifted and we're in a position to implement our Phase IIIb program as planned," he reported.
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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.’
Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
