FDA approves leucovorin – but not for autism
The FDA stops short of approving leucovorin for autism, but will its clearance for ultra-rare condition CFD-FOLR1 lead to more off-label prescribing?
BioNTech bigwigs will step down to form new mRNA company
The co-founders of mRNA specialist BioNTech – husband and wife team Uğur Şahin and Özlem Türeci – have said they are leaving to set up a new company.
Lundbeck names AI head in quest to become 'bionic' company
Lundbeck has appointed Markus Kede to the newly created role of chief AI officer, charged with driving its ambition to become a 'bionic' company.
BMS eyes another celmod filing in myeloma after phase 3 win
Bristol Myers Squibb now has positive phase 3 data under its belt for celmod mezigdomide, as it waits for an FDA verdict on lead drug iberdomide.
FDA cuts testing requirements for biosimilars once again
The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.
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