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AZ grabs FDA nod for Ultomiris in rare kidney disease IgAN
AstraZeneca has staked a claim to the increasingly crowded IgAN market with an accelerated approval from the FDA for Ultomiris, its fifth indication.
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Despite US policy changes, drug prices stay stubbornly high
US policy changes designed to curb drug prices seem ineffective, as the annual cost of new medicines still exceeds $250,000, curbing patient access.
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GSK wins FDA green light for chronic hep B treatment Hibsago
GSK's antisense-based drug for chronic hepatitis B virus (HBV) infection, Hibsago, has been approved in the US, its second major market after Japan.
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The pre-commercial case for connecting data before acquiring...
For EBPs, launch requires a data strategy that starts with agreement on the KPIs, and those depend on the therapeutic areas.
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Compounded tirzepatide recalled after FDA warning
A compounded version of Eli Lilly's injectable weight-loss and diabetes therapy tirzepatide has been recalled from sale due to sterility concerns.
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