FDA Complete Response Letter

The FDA issued a Complete Response Letter (CRL) to Sesen Bio Inc's (NASDAQ: SESN) bladder cancer candidate Vicineum. The Company acquired the antibody-drug conjugate in the buyout of Viventia back in 2016. Sesen described the reason for the CRL as a combination of...

Wrapped up in its Q2 earnings release, Axsome Therapeutics Inc (NASDAQ: AXSM) said that on July 30, it received an FDA letter for a marketing application for AXS-05 for the treatment of major depressive disorder (MDD). The letter stated that the deficiencies preclude discussion of...

Shares of Dynavax Technologies Corporation (NASDAQ: DVAX) plunged more than 70 percent after the disclosure of a Complete Response Letter (CRL) from the FDA on its Biologics License Application for HEPLISAV-B. The drug candidate is meant for immunization of adults 18 years and older affected by...

Shares of AstraZeneca plc (ADR) (NYSE: AZN) were trading lower by more than 1.5 percent early Friday after the company confirmed it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration relating to its New Drug Application (NDA) for sodium zirconium cyclosilicate,...