FDA– tag –
-
Implantable and Non-Invasive Continuous Health Sensors Advance Personalized Medicine with AI and Wireless Tech, Enabling Up to 1-Year Subcutaneous Deployment
ELE Times India Overview Continuous health sensors, encompassing both implantable and non-invasive wearables, are fundamentally transforming modern medicine. Continuous glucose monitors (CGMs) for diabetes management stand out as one of ... -
FDA Approves Finger-Prick Free Dexcom Stelo and Abbott Libre CGMs, Revolutionizing Metabolic Management for Non-Insulin Users
Mattioli 1885 / GoodRx USA Overview The FDA has approved continuous glucose monitoring (CGM) systems like Dexcom Stelo and Abbott's Lingo (and FreeStyle Libre series), eliminating the need for traditional finger-prick tests and marking a... -
FDA Endorses ‘Prior Knowledge’ Use in Gene Therapy Development, Streamlining Review for AAV, Nanoparticle Delivery Systems, and Cell Therapies
Hogan Lovells USA Overview The U.S. Food and Drug Administration (FDA) issued guidance endorsing the use of 'Prior Knowledge' in the development of genome editing products, a policy expected to streamline drug development and review proc... -
ENCell Secures US Clinical Manufacturing Contract for Ingenium Therapeutics’ NK Cell Therapy Gengleucel, Expanding Global CDMO Operations
Bio South Korea Overview ENCell, a South Korean CDMO specializing in cell and gene therapy, has signed an additional CMO contract with Ingenium Therapeutics for the manufacturing of clinical trial materials for its NK cell therapy candid... -
Exosome Treatments in Aesthetics Remain FDA Unapproved with Safety Warnings: Emphasizing Evidence-Based Approaches
Aesthetic Med Guide USA Overview The U.S. FDA has reiterated that no exosome products are approved for aesthetic purposes and has issued a public safety alert against the use of unapproved products. This article details the scientific ba... -
FDA Expedited Pathway Guide: Strategic Selection of Fast Track, Breakthrough Therapy, and RMAT
Boyd Consultants USA Overview The FDA offers several expedited programs to accelerate innovative drug development, including Fast Track, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT). This article outlines the d... -
FDA Issues Draft Guidance to Streamline Regulatory Submissions for Cell and Gene Therapy Products by Leveraging Prior Knowledge
Pharmuni USA Overview The U.S. FDA has released new draft guidance aimed at accelerating the development of cell and gene therapy products for rare diseases. This guidance permits developers to leverage existing scientific, manufacturing... -
BioCardia’s CardiAMP Autologous Cell Therapy Accelerates Towards Global Approval for Heart Failure
MerlinTrader (BioCardia分析) USA Overview BioCardia's CardiAMP autologous bone marrow cell therapy for cardiovascular disease has achieved significant regulatory milestones. The U.S. FDA confirmed that the ongoing Phase 3 CardiAMP Heart ... -
Beam Therapeutics’ Gene-Editing Candidate BEAM-302 Shows Positive Clinical Data in AATD Treatment, Hinting at Accelerated FDA Pathway
Simply Wall St USA Overview Beam Therapeutics reported positive clinical trial data for its gene-editing candidate, BEAM-302, demonstrating sustained protective protein levels in the treatment of Alpha-1 Antitrypsin Deficiency (AATD). Th... -
Century Therapeutics’ iPSC-Derived Type 1 Diabetes Therapy CNTY-813 Demonstrates Durable Glucose Control and Immune Evasion in Preclinical Studies
BioSpace (Century Therapeutics) USA Overview Century Therapeutics announced groundbreaking preclinical data for its iPSC-derived islet replacement therapy, CNTY-813, designed for Type 1 Diabetes (T1D) with Allo-Evasion™ 5.0 technology, a...
