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Orphan drugs account for about one-third of the 41 novel approvals granted by the FDA’s Center for Drug Evaluation and Research so far in 2021, a ratio that is replicated in the center’s three most re
There are five novel agents with October 2021 goal dates on the FDA’s user fee calendar, but at least one – Omeros Corporation ’s narsoplimab – already appears unlikely to see a decision, let alone a
Having overcome some concerns raised at an US Food and Drug Administration advisory committee review, ChemoCentryx, Inc. is now in the position to bring Tavneos (avacopan) to market for ANCA vasculi
Vifor Pharma Group has had a very quiet year to date on the business development front but remains confident about completing "at least two in-licensing deals, product acquisitions or corporate tran