German pharma Bayer has sent its BLA to the FDA for its long-acting Hemophilia A medication BAY94-9027.

Eli Lilly and Incyte say they plan'to refile their FDA-rejected arthritis candidate baricitinib by the end of January for possible approval in 2018.

Industry leaders put together the wish list to influence an upcoming deal between the sector and an increasingly interventionist government.

The spectacular rehabilitation of Aveo's cancer drug tivozanib continues with E.U. approval as a treatment for advanced kidney cancer.

The priority review means Roche will learn what the FDA makes of the benefits and risks of emicizumab by Feb. 23.

MabVax Therapeutics is hiring an investment bank to help it find a buyer or sell off its assets as it continues to struggle for cash.

Alkermes has started a rolling application to market its twice-failed antidepressant ALKS 5461.

Regulators stand accused of waving through drugs on the basis of slight data and then failing to ensure postapproval trials validate the decision.

Bluebird Bio plans to bring its gene therapies to market in Europe before the U.S., thanks to a favorable regulatory pathway.