Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Built with an audacious goal to use AI to unlock the secrets of protein structure and function, Generate Biomedicines believes it is now on the cusp of a drug discovery revolution.