regulatory approval

News

Bayer bags first world approval for hot flush therapy

Bayer has its first regulatory approval for non-hormonal menopause treatment elinzanetant – in the UK – as it chases down a rival drug from Astellas.

News

FDA clears new, safer regimen for Lilly's Alzheimer's drug

Eli Lilly has won FDA approval for a new regimen for its Alzheimer's disease therapy Kisunla, which carries a reduced risk of side effects.

News

First malaria drug for newborns and young infants cleared

A new formulation of Novartis' antimalarial Coartem has become the first medicine to be approved for use in very young children.

News

KalVista bags FDA approval for delayed oral HAE drug

KalVista has brought the first oral, on-demand treatment for hereditary angioedema attacks to the US market.

News

AZ claims EU okay for Imfinzi in bladder cancer

AstraZeneca passes another milestone in its journey to rebuild Imfinzi's presence in bladder cancer, a key growth driver for the drug.

News

Dizal set to bring lung cancer drug Zegfrovy to US

Dizal gets US approval for an oral therapy for EGFR exon 20-mutated NSCLC, offering some patients an alternative to J&J's intravenous Rybrevant.

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