The FDA's Breakthrough Therapy Designation for balovaptan was primarily based on efficacy findings in the VANILLA study, a Phase II trial of balovaptan in adults with ASD. Source: BioSpace

the FDA has determined that it cannot approve the NDA in its present form and provides specific reasons for this action along with recommendations needed for resubmission. Source: BioSpace

AbbVie provided an unexpectedly strong 2018 guidance revision, largely built on the new corporate tax rate. Source: BioSpace

A look at three small biotechs that big drugmakers are drooling over. Source: BioSpace

Generic drug giant spokesperson says resignation is effective immediately as Desai pursues other opportunities. Source: BioSpace

Apostle, headquartered in Sunnyvale, Calif., hopes to file an IPO or establish other strong business collaborative routes in five years. Source: BioSpace

A look at six biopharma companies that may have major stock catalysts this year. Source: BioSpace

This is a market like the world has never seen. Source: BioSpace

With a trial on hold for more than six months, InVivo has been burning through cash and may not have enough financing to continue operations for much longer. Source: BioSpace

The FDA will establish a council to oversee all animal studies under the agency’s purview. Source: BioSpace