Under round six of the user fee agreement with industry, the FDA is pledging to explore the use of real-world evidence, strengthen the patient's voice in the drug review process and boost the agency's postmarketing surveillance abilities.
The FDA has decided to join the real world next year – or at least, explore it, in terms of what type of data it will consider from innovator drug makers.
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The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.
Merck is investing $ 1bn in a Delaware facility to produce Keytruda and expand biologics manufacturing amid US tariff concerns.
Europe's biopharma sector could suffer if the Trump administration incentivizes US investment but VC leaders believe the region can still thrive and potentially capitalize on instability elsewhere.
