Portola Pharmaceuticals, Inc.

AstraZeneca PLC ’s anticoagulant reversal agent Andexxa (andexanet) will not convert to full approval, the company told the Pink Sheet after the US Food and Drug Administration issued a complete res

The US FDA Center for Biologics Evaluation and Research’s decision-making on when to require that confirmatory trials be up and running at the time of accelerated approval will rest heavily on the siz

Neurocrine Anticipates ‘Bumpiness’ As Delta Restricts Clinic Access Neurocrine Biosciences, Inc. sees potential headwinds in the second half of 2021 as clinics implement restrictions due to the sprea

Complete response letters are becoming a more likely outcome for applications with the FDA’s marquee expedited review status, an analysis using the Pink Sheet’s US FDA Performance Tracker shows. Produ