regulatory

News

Unicycive Therapeutics' hopes of getting FDA approval of its drug for hyperphosphataemia in dialysis patients have been knocked back again.

News

Eli Lilly, Regeneron, and five other drugmakers will take part in an FDA pilot designed to make it quicker and easier to set up manufacturing plants.

R&D

The US pharmaceutical industry is entering a new phase of supply chain transformation.

News

A unanimous endorsement from FDA advisors brings Moderna's RNA-based seasonal influenza vaccine a step closer to US approval.

News

Shares in uniQure have rocketed this morning, as it emerges that the FDA will not require it to run a new trial of Huntington's gene therapy AMT-130.

News

The FDA is due to deliver a verdict in February on Gilead's once-weekly pill for HIV PrEP, which could expand the options available to patients.