There has been “a lot of fear and anxiety” resulting from the Trump Administration’s early actions aimed at freezing grants and FDA communications, NORD’s Pamela Gavin says.
The US Health and Human Services Department’s communications freeze and President Trump’s threat to halt federal grant funding have stressed the rare disease community.
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Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.
The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.
