EC approves argenx’s efgartigimod alfa for CIDP treatment
Pharmaceutical Technology
JUNE 23, 2025
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Pharmaceutical Technology
JUNE 23, 2025
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Pharmacy Times
JUNE 23, 2025
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years. The 505(j) pathway is how you get a multisource generic.
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Pharmaceutical Technology
JUNE 20, 2025
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Pharmaceutical Technology
JUNE 19, 2025
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Pharmaceutical Technology
JUNE 23, 2025
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Pharmaceutical Technology
JUNE 20, 2025
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Pharmaceutical Technology
JUNE 23, 2025
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