Biopharmaceutical
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FDA Commissioner Marty Makary out following policy dispute
Makary stepped down amid a widening rift over tobacco regulation and a series of contentious decisions that reshaped the FDA’s internal politics.
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FDA takes steps toward real‑time clinical trials
The regulator said the goal is to speed up the development of promising therapies by addressing longstanding early-phase delays.
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FDA to streamline biosimilar development to lower drug prices
New federal guidance recommends using drugs approved outside of the US as comparators to cut down on pricey pharmacokinetic testing.
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FDA launches program to bolster domestic drug manufacturing
The PreCheck program aims to make it significantly less onerous to set up domestic manufacturing plants provided they align with US national priorities.