Arthritis Advisory Committee says belimumab efficacy is not shown for full spectrum of the disease, so the biologic should go to market with appropriate caveats.
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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.’
A newly launched UK government inquiry is seeking to learn how viable it would be to bring back domestic control over the entire drug manufacturing pipeline.
Learn how advances in vaccine adjuvants are shaping the future of global health and driving more effective immunization strategies
Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
