Mystery cloaks an ASCO plenary lung cancer survival result.

How a rare disease drugmaker won FDA approval after a clinical trial disappointed.

A preliminary readout from a study could vindicate Allogene Therapeutics' stubborn belief in its off-the-shelf CAR-T treatment.

Recent decisions at the FDA threaten to turn its disagreements with the drugmaker UniQure into another political headache for the Trump administration.

With the current leadership of the FDA, the rare-disease community is suffering whiplash. Drugmakers are frustrated. And investors are sitting on their wallets.

Prasad changed jobs but his conservative regulatory doctrine remains the same, particularly for cell and gene therapies. The approval bar is much higher now.

Ocular Therapeutix and Eyepoint Pharmaceuticals are developing competing eye treatments, and the competition appears to be getting heated.

A liver-safety risk puts the future of Corcept Therapeutics' experimental drug in doubt.