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Enhertu OK ends 10-year EU gap in frontline breast cancer
Enhertu plus Perjeta has become the first new frontline therapy approved for advanced HER2-positive breast cancer in the EU for over a decade.
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White House signs pricing deals with nine more pharmas
Nine mid-sized pharmas have signed up for the Trump administration's Most-Favoured Nation (MFN) pricing deals, pledging almost $20bn in investments.
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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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