FDA starts review of AZ's COPD blockbuster hope
The FDA has started a priority review of AstraZeneca's first-in-class IL-33 inhibitor tozorakimab for COPD, setting up a decision in Q1 of 2027.
FDA makes acting CDER, CBER chiefs permanent
Michael Davis becomes the permanent head of CDER, while Karim Mikhail is confirmed as permanent CBER director and the FDA names its first AI leader.
Brainomix AI lends weight to Endeavor Bio's IPF trial data
An AI-based imaging tool from Brainomix has been used to enrich data from a phase 2a trial of Endeavor's idiopathic pulmonary fibrosis drug taladegib.
Pharvaris plans filings for HAE drug after pivotal trial win
Pharvaris has reported positive data from a phase 3 trial of its drug for preventing HAE attacks, setting up marketing applications next year.
Sandoz says it is entering "golden decade" in biosimilars
Sandoz said today it intends to double net sales between 2025 and 2035, fuelled by an acceleration in biosimilar medicine development.
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