regulatory approval

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GSK's RSV shot cleared in US for all adults

GSK is back on level pegging with its rivals in the RSV vaccine category in the US, after getting FDA approval for Arexvy in the 18 to 49 age bracket.

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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?

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Incyte breaks new ground in anal cancer with EU approval

Incyte claims EU approval for Zynyz as the first systemic therapy for anal cancer, as J&J gets the nod for wider use of Akeega in prostate cancer.

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China's clears Pfizer GLP-1 ecnoglutide for weight loss

Pfizer has claimed its first regulatory approval for a GLP-1 agonist in obesity, getting a green light in China for Sciwind-sourced ecnoglutide.

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J&J's Tecvayli claims third national priority FDA approval

J&J claims the FDA's third national priority voucher approval, advancing a Tecvayli-based regimen for multiple myeloma into the second-line setting.

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Ascendis scores FDA approval for weekly dwarfism drug

Children with achondroplasia will soon have the option of a once-weekly - rather than daily - injection, courtesy of Ascendis' newly approved Yuviwel.

GSK's RSV shot cleared in US for all adults

FDA approves leucovorin – but not for autism

Incyte breaks new ground in anal cancer with EU approval

China's clears Pfizer GLP-1 ecnoglutide for weight loss

J&J's Tecvayli claims third national priority FDA approval

Ascendis scores FDA approval for weekly dwarfism drug

Novo sues Lilly over 'misleading' GLP-1 ad campaigning

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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