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Third time lucky for Replimune as FDA OKs melanoma drug
At its third attempt, Replimune has finally won FDA approval for its advanced melanoma treatment RP1, now named Tudriqev and its first product.
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Novo Nordisk wins Netherlands GLP-1 compounding lawsuit
A Dutch compounding pharmacy has been ordered to stop distributing a compounded nasal spray version of Novo Nordisk's GLP-1 agonist semaglutide.
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Takeda's first-in-class narcolepsy drug claims FDA approval
Takeda's orexin agonist Orzeyful is the first drug approved in the US that can treat the "full range" of narcolepsy type 1 symptoms, says the FDA.
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Senate confirms Erica Schwartz as CDC Director
CDC has a permanent director in place at last, after the Senate confirmed Erica Schwartz's nomination to what has become a politically charged role.
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FDA clears Moderna's mRNA-based seasonal flu shot
After a series of regulatory twists and turns, the FDA has approved Moderna's mRNA-based influenza vaccine mFlusiva.
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