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FDA clears Takeda, Protagonist's first-in-class PV drug
Takeda and Protagonist's hepcidin mimetic rusfertide is the first hepcidin mimetic to be approved by the FDA for blood cancer polycythaemia vera.
Market Access
Navigating Europe's AI regulatory labyrinth: A strategic gui...
For US drug developers, bringing AI tools across the Atlantic introduces steep regulatory hurdles.
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Roivant wins FDA approval for first targeted dermatomyositis...
Roviant & Priovant Therapeutics finally secure US approval for once-daily oral TYK2/JAK1 inhibitor, Lisraya (brepocitinib), for dermatomyositis.
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FDA approves new COVID shots - with same restrictions as las...
FDA has approved the 2026 COVID vaccine formulations, but last year's narrower recommendation stands, leaving open questions about access.
Market Access
Biotech funding has returned. The bar has moved with it.
For biotech sponsors, the question worth asking is not whether the rebound is real, but what it is actually rewarding.
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