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- FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory workAI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…
- Spyre Therapeutics reports SPY072 fails psoriatic arthritis trial as Ideaya halts eye cancer studySpyre Therapeutics announced that its long‑acting anti‑TL1A candidate, SPY072, did not meet the primary endpoints in a psoriatic arthritis trial. The result adds to recent setbacks for Spyre in ot…