Biohaven ALS drug blocked by FDA over manufacturing issue

Lawmaker weighs in on Gottlieb switch to industry

Medtronic recalls insulin pumps vulnerable to hacking

Gottlieb joins Pfizer board, a few weeks after quitting FDA

Former FDA commissioner Scott Gottlieb has stoked controversy after being appointed to Pfizer’s board of directors, just a few weeks after leaving his government post.

FDA approves Herceptin biosimilar as US patent expires

The FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer blockbuster’s patent expiry.

Catalyst squares up to FDA over rival drug approval

Catalyst Pharma is suing the FDA over its approval of a potential rival to its rare disease therapy Firdapse, calling it “arbitrary, capricious, and contrary to law.”