Abiomed gets its chance before FDA with TAH (total artificial heart)
This article was originally published in Clinica
An FDA advisory committee will meet on June 23 to consider Abiomed's application to market the first completely self-contained total artificial heart (TAH).
You may also be interested in...
Dispatches from a world turned upside down include FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.
A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.
Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.