Staffing cuts and other administrative disorders leads to a review extension on a clinical hold review on Neurizon Therapeutics NUZ-001 and its use f...
FDA issues an alert on all Baxter Novum IQ Large Volume Pumps and Novum IQ Syringe Pumps after becoming aware of a company notification to users that ...
FDA extends by three months its review of an Omeros resubmitted BLA for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microa...
FDA approves a Precigen BLA for Papzimeos (zopapogene imadenovec-drba), a non-replicating adenoviral vector-based immunotherapy for treating adult pat...
FDA issues an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Heart Vent Catheters be...
A Phase 3 study of Pfizers investigational sickle cell disease drug inclacumab fails to meet the primary endpoint.
FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-101, an investigational gene-edited cell treatment for sick...
The Multidisciplinary Association for Psychedelic Studies calls on HHS and FDA to quickly approve its NDA for MDMA-assisted therapy that was rejected ...
