The agency appears ready to narrow bioequivalence standards across the board for generic drug approvals and set up specific requirements for certain drugs with complicated dosing, but is looking to the Pharmaceutical Science advisory panel for final advice on whether the moves are necessary.
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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.’
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
