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FDA clears Astellas' Vyloy as first claudin 18.2 cancer drug

At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for certain gastric cancers.

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AbbVie gets continuous Parkinson's drug over the line in US

AbbVie has finally claimed FDA approval for its advanced Parkinson's disease therapy Vyalev, 18 months after the US regulator turned it down with a request for more data.

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Australia joins EU in turning down Alzheimer's drug Leqembi

Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks.

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FDA set to decide on GSK's gepotidacin antibiotic in March

The FDA has started a priority review of GSK's gepotidacin, which could become the first in a new class of oral antibiotics for uncomplicated urinary tract infections (uUTIs) in over 20 yea

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GSK turns its guns on Moderna in mRNA jab patent dispute

GSK has filed a pair of lawsuits against Moderna, claiming infringement of patents covering mRNA vaccines for COVID-19 and respiratory syncytial virus (RSV).

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