Biologics Regulatory Spine BioRestorative Granted Type B Meeting with FDA to Discuss Accelerated BLA Approval Pathway for BRTX-100 in Chronic Lumbar Disc Disease byJosh SandbergNovember 17, 2025
Recon Regulatory Zimmer Biomet Announces FDA Breakthrough Designation for World’s First Iodine-Treated Total Hip Replacement System byTim AllenOctober 28, 2025
Neuro Regulatory CND Life Sciences is Granted FDA Breakthrough Device Designation for Its Skin Biopsy-Based Syn-One Test® byNoah SimmonsOctober 7, 2025
Biologics Regulatory Rocket aborts mission to get gene therapy approved by FDA for rare bone marrow disorder byWill SandbergOctober 3, 2025
Regulatory FDA halts new device submissions during government shutdown byWill SandbergOctober 2, 2025
Regulatory As shutdown begins, FDA to stop accepting new drug submissions byWill SandbergOctober 1, 2025
Regulatory Envoy Medical Advances Commercialization Planning for Breakthrough Hearing Device as FDA Clinical Trial Remains On Track byWill SandbergSeptember 26, 2025
Recon Regulatory ZKR Orthopedics Announces First Patella LIFT™ Surgeries on the East Coast at Hospital for Special Surgery in Enrollment of FDA PELICAN Trial byJosh SandbergSeptember 16, 2025
Regulatory Top Stories Sawbones® and Numalogics Achieve First-Ever FDA Qualification of an Orthopedic Device Mechanical Test Under MDDT Program byTim AllenMay 20, 2025
