FDA– tag –
-
Business Trends
Beam Therapeutics Pursues Accelerated Approval Pathway for BEAM-302 in Alpha-1 Antitrypsin Deficiency, Citing Positive Phase 1/2 Clinical Data
Simply Wall St USA Overview Beam Therapeutics announced updated Phase 1/2 clinical trial data for BEAM-302, its treatment for Alpha-1 Antitrypsin Deficiency (AATD), showing an acceptable safety profile and promising biomarker data indica... -
Biosensors & POCT
FDA Greenlights Pfizer-BioNTech’s XFG-Adapted COVID-19 Vaccine for 2026-27 Season, Bolstering Defense Against Evolving Variants
Medscape USA Overview The U.S. FDA has authorized the Pfizer-BioNTech XFG-adapted COVID-19 vaccine for the 2026-27 season, marking a significant advancement in confronting the persistently evolving SARS-CoV-2 virus. This updated mRNA vac... -
New Technology
Beyond Air’s LungFit GO Device Receives FDA Breakthrough Designation, Simplified Biosensor Manufacturing Technology Could Improve Organ Transplantation
Health Tech Publication USA Overview Beyond Air has received FDA Breakthrough Device Designation for its LungFit GO device, intended to treat nontuberculous mycobacterial pulmonary disease. This designation aims to accelerate the develop... -
Market Trends
Five Key Trends in Diabetes Technology for 2026: Longer-Lasting CGMs, OTC Expansion, and Multi-Biomarker Monitoring Lead Innovation
DiabeticSupplieInc.com Unknown Overview Five major trends are shaping diabetes technology in 2026, including longer-lasting continuous glucose monitoring (CGM) sensors like the FDA-cleared Dexcom G7 15-day system, expanded CGM access for... -
Market Trends
FDA Approves Dexcom’s Stelo System as First Over-the-Counter Continuous Glucose Monitor for Children Ages 2-18
RadioWHAT (Facebook) USA Overview The FDA has approved Dexcom's Stelo system as the first over-the-counter (OTC) continuous glucose monitor (CGM) available for children aged 2 to 18 without a prescription. This device provides 15-minute ... -
Market Trends
Abbott’s Libre Duo 10-Day System Receives FDA Authorization as First Wearable Continuous Glucose-Ketone Monitor in U.S.
Diabetes Education Services USA Overview Abbott has secured FDA authorization for its Libre Duo 10 Day Continuous Dual Glucose-Ketone Monitoring System, making it the first wearable device in the U.S. and globally to continuously monitor... -
New Technology
FDA Marks New Era in Diabetes Care with First Dual Glucose-Ketone Wearable and OTC Pediatric CGM
FDA News / Health Technology News USA Overview The U.S. FDA has ushered in a new chapter for diabetes technology, authorizing Abbott's Libre Duo as the first wearable device for continuous dual monitoring of glucose and ketones, and clea... -
Market Trends
CAR T-Cell Therapy Clinical Trial Landscape for Non-Hodgkin Lymphoma Expands with Over 70 Companies Developing Next-Gen Treatments
GlobeNewswire Global Overview A report by DelveInsight, released via GlobeNewswire, offers a detailed analysis of the CAR T-cell therapy clinical trial landscape for Non-Hodgkin Lymphoma (NHL). The report highlights over 70 companies adv... -
Market Trends
Global Cell and Gene Therapy Manufacturing Services Market to Surge to $31.3 Billion by 2035, Driven by Regulatory Modernization
openPR.com (DataM Intelligence) Global Overview According to DataM Intelligence, the global cell and gene therapy manufacturing services market is projected to reach $8.77 billion in 2026, growing rapidly to $31.3 billion by 2035 with a ... -
iPS Cells & Regenerative Medicine
Beam Therapeutics’ Base Editing Therapy BEAM-302 Shows Rapid, Sustained AAT Increase in Phase 1/2 for Alpha-1 Antitrypsin Deficiency, Targets Accelerated Approval
GlobeNewswire / Beam Therapeutics Press Releases USA Overview Beam Therapeutics presented updated Phase 1/2 clinical data for its base editing therapy, BEAM-302, for alpha-1 antitrypsin deficiency (AATD) at the European Respiratory Socie...