Akcea sees the filing positioning it to bring the treatment of familial chylomicronemia syndrome to market in the U.S. next year.
Daiichi Sankyo has cut and run from its $650 million pain alliance with Charleston Laboratories seven months after receiving a CRL.
RBM is, above all, an opportunity to practice mindfulness in collecting clinical trial data within the site- and patient-centric environment.
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 stock exchange has given Auris until Oct. 2 to meet the stockholders’ equity requirement.
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.