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MSD, Daiichi pull filing for lung cancer candidate I-DXd
MSD and Daiichi Sankyo's regulatory efforts for their ADCs for cancer have stuttered again, with a withdrawn filing for lung cancer candidate I-DXd.
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FDA approves Mirum's oral drug for rare disease FOP
Mirum's new oral therapy for rare bone disease fibrodysplasia ossificans progressiva (FOP) looks set to challenge Regeneron's intravenous Pasatru.
Market Access
Is the next generation of Chinese biotech ready to go global...
Will Chinese biotechs continue to transfer most ex-China rights, or retain their strongest assets and compete internationally themselves?
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EU clears first drug therapy for rare disease cALD
Neuraxpharm and Minoryx' Nezglyal has become the first approved drug therapy in the EU for rare neurodegenerative disease cALD.
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FDA starts speedy review of Imfinzi in bladder cancer
AstraZeneca is closing on FDA approval of a new bladder cancer indication for Imfinzi that could help to fend off encroachment from MSD's Keytruda.
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