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.
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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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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Expanded US Imaavy approval first ever for wAIHA
The FDA has approved Johnson & Johnson's Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune haemolytic anaemia (wAIHA).
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