Lyme ImmunoBlot Receives FDA Clearance
Newly Cleared Technology is a Game Changer for the Diagnosis of an Often Debilitating Disease ID-FISH Technology, Inc., a leading provider of diagnostic tools for...
Neurocare Group Receives FDA Clearance for Its Industry-Leading Intermittent Theta Burst Stimulation (iTBS) Protocol for Transcranial Magnetic Stimulation (TMS)
neurocare is pleased to announce that it has received FDA clearance for its industry-leading intermittent Theta Burst Stimulation (iTBS) protocol, available across its Apollo TMS...
ASTCT Applauds FDA Approval of Axatilimab-Csfr for the Treatment of Chronic Graft-Versus-Host Disease (cGVHD)
The American Society for Transplantation and Cellular Therapy (ASTCT) applauds the U.S. Food and Drug Administration’s (FDA) approval of axatilimab-csfr (Niktimvo, Incyte Corporation), a significant new...
American Society for Transplantation and Cellular Therapy Applauds FDA Approval of TECELRA® for Synovial Sarcoma Treatment
The American Society for Transplantation and Cellular Therapy (ASTCT®) applauds the U.S. Food and Drug Administration's (FDA) accelerated approval of TECELRA® (afamitresgene autoleucel) for the...
Analysis Finds Misinformation About Interchangeable Biosimilars Undermining US Health Policy, Physician Confidence, and Patient Health
The Alliance for Safe Biologic Medicines (ASBM) announces the publication of a paper underscoring the critical role of the FDA’s interchangeable biosimilar data requirements in...
Amin Wasserman Gurnani Welcomes Former Acting Director for FDA’s Office of Dietary Supplement Programs as Co-Chair of the Firm’s Regulatory Group
Robert “Bob” Durkin to co-lead regulatory practice with partner Rend Al-Mondhiry Amin Wasserman Gurnani (AWG) is pleased to announce that Robert Durkin has joined the...
Neuro20 Sparks Hope for Long COVID Recovery
White Paper discussing patient improvements and potential mechanisms for patients with Long COVID. Neuro20 Technologies Corp., announces release of a White Paper discussing patient improvements...
Statement by Fragrance Creators Association Calling on Congress to Provide Funding to Implement Modernized Cosmetic Regulations
Fragrance Creators Association (FCA) President and CEO Farah K. Ahmed issued the following statement on funding to support the Food and Drug Administration’s (FDA) implementation...
h2o Announces FDA Listing of Apple Watch-Based Cueing Feature ‘Foggy’ for Freezing of Gait in Parkinson’s Disease
The innovative new feature within the Parky app for Apple Watch is available by prescription for people with Parkinson’s disease. h2o therapeutics today announced that...
ASTCT Supports the FDA’s Approval of Earlier Use of CAR T-Cell Therapy for Multiple Myeloma
The Food and Drug Administration approves CAR T-Cell therapy Carvykti® as a second-line treatment and the CAR T-Cell therapy Abecma® as a third-line treatment for...