Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.

Two companies looking to challenge Merck’s Keytruda with new combinations have had contrasting reactions from investors

While the general lack of an overall survival benefit for MacroGenics’ drug in later-line breast cancer was not surprising, OS data were seen as important for commercial uptake of the drug.

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.