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Case Study: 505(b)(2) filing pathway – USFDA approval of Vumerity

Biogen, global biotechnology company, and Alkermes, global biopharmaceutical company, announced that the US Food and Drug Administration (FDA) approved Vumerity (diroximel fumarate), a novel oral fumarate with a distinct chemical...
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Insighht on USFDA approval of Trikafta

Vertex Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA). This is a landmark approval where Vertex’s Trikafta earned this approval only three months after the application was...
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KPE-C-080 Certificate Course in Pharma Business Development & Licensing

TypeOnline Course
Student Enrolled1
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TypeOnline Course
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Student Enrolled2
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