Human Drugs
Clinical Hold Lifted on Covid Antibody Cocktail
Immunome plans a Phase 1b trial after FDA lifts a clinical hold on its antibody cocktail (IMM-BCP-01) for treating Covid-19.
Biologics
Panel to Mull Covid Vaccine Modifications Due to Variants
FDA says an agency advisory committee will discuss 4/6 what the optimal strain composition might be for Covid-19 vaccines/boosters to address emerging...
Medical Devices
Abbotts Leadless Pacemaker Approved for Slow Hearts
FDA approves Abbotts Aveir VR single-chamber leadless pacemaker for treating patients with slow heart rhythms.
Federal Register
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/1/2022.
FDA General
Product Approval Summaries
FDA Review posts product approval summaries for the week ending 4/1/2022.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Fast Track for Hemophilia A Gene Therapy
FDA grants ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patients.
Human Drugs
Merck Pediatric Pneumococcal Vaccine Review Extended
FDA extends by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in infants and children.
Biologics
Y-mAbs Therapeutics Re-files Omburtamab BLA
Y-mAbs Therapeutics resubmits a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma that addresses FDA cited de...
Human Drugs
e-Certificates of Pharmaceutical Product Now Have QR Code
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product that also include a unique Quick Response code to verify authenticit...
