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.
News
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.
News
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.
News
ViiV wins US approval for HIV treatment in newborn babies
The US FDA has green lit ViiV Healthcare’s Tivicay PD (dolutegravir) for the treatment of HIV-1 in children weighing at least 2 kg.
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