In a seminal moment for the Belgian biotech, Ablynx has filed its first-ever drug for approval.

It’s the fourth-quarter clear out, and AstraZeneca has pulled the plug on a combo of its immuno-oncology candidate as well as axing a test of its biologic arm’…

The executive team from AstraZeneca met this week with the U.K. government to discuss the country leaving the European Union, as its CEO says there are “…

The chief of AstraZeneca, Pascal Soriot, said during the Big Pharma’s financials this morning that he wants a “science-led FDA” as President Donald Trump'…

Lawmakers have sent a letter to the White House urging Trump to come clean on what a hiring freeze means for the FDA.

Seres Therapeutics has plotted a path forward for its Clostridium difficile program after digging into the data to learn where it went wrong in phase 2.

FibroGen has posted positive phase 3 data on its AstraZeneca-partnered anemia drug.

Back in the summer, Novartis quietly announced that the FDA had rejected its application for a biosimilar version of blockbuster drug Neulasta (pegfilgrastim…

The United Kingdom government is holding a series of meetings with the CEOs of top-10 pharma companies in a bid to understand how it can attract R&D…

Regulatory