Enzyvant Sciences resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for the company’s tissue-based regenerative pediatric congenital athymia therapy RVT-802.
The U.S. Food and Drug Administration declined to approve Enzyvant’s regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about the privately held drug developer’s manufacturing.
Mallinckrodt plc announced positive top-line results from the global biopharmaceutical company’s pivotal Phase 3 clinical trial of the investigational StrataGraft regenerative tissue.
Startup biotech companies have a new place to call home in downtown Manhattan thanks to Alexandria Real Estate Equities.
Drugmaker Allergan Plc said it would buy LifeCell – a regenerative medicine unit owned by privately held Acelity LP Inc. – for $2.9 billion in cash.