News Bayer gets sought-after heart failure use for Kerendia Bayer's Kerendia has won FDA approval for a new heart failure indication thought to be pivotal for the product's blockbuster sales prospects.
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 Just how radical is the FDA's complete response letter move? The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.
News EU President fends off no-confidence vote over Pfizer texts EU President Ursula von der Leyen has survived a no-confidence vote over text messages she sent to Pfizer's CEO about COVID-19 vaccine procurement.
News NICE backs new drugs for Crohn's disease, lymphoma Eli Lilly's Omvoh has been recommended for use in Crohn's disease by NICE, while BeOne's Brukinsa gets the go-ahead for mantle cell lymphoma.
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 UK project addresses capacity issue in CGT manufacturing A UK consortium has been set up to tackle a major issue in the development of cell and gene therapies (CGT) – a lack of manufacturing capacity.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face