FDA Thwarts Leo Pharma's US Launch Plans For Tralokinumab
Agency Issues CRL For Atopic Dermatitis Drug
A week after getting the thumbs-up from the CHMP for tralokinumab, the Denmark-based dermatology specialist has been hit by a complete response letter from US regulators requesting more data about a device component of the IL-13 inhibitor.
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Biotech stock indices have seen a recent recovery but remain well below their 2021 peaks raising questions about the likelihood of raising money for R&D. The number of companies announcing leadership changes, shifting pipeline priorities and job cuts is rising as a result.
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.
Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker