Tirzepatide heads for its first FDA approval and Enhertu eyes an earlier setting, as Verrica and Axsome keep their fingers crossed.
Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
Chemocentryx and Avadel will also see important FDA regulatory action this month, while Omeros gets another delay.
Extending a pulmonary hypertension drug’s lifecycle could help battle generic erosion, but investors might have been looking for a more transformative deal.
Alnylam has secured its first approval, but history suggests that launch will be far from easy.
The drugs of 2014 that went supernova and those that failed to make orbit.