Go or no go? Merck, Regeneron and Alexion await US expansion

Has the summer lull begun early? Only a handful of novel projects are set to come before the US FDA next month, including Xeris’s glucagon pen for severe hypoglycaemia, and Amag and Palatin’s Vyleesi for female sexual dysfunction.

But the agency will be kept busy with decisions on new indications for big products like Merck & Co’s checkpoint inhibitor Keytruda, Sanofi and Regeneron’s Dupixent, and Alexion’s rare disease blockbuster Soliris.