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Biologics CDMO Market to Reach $38.29 Billion by 2031, Fill-Finish Emerging as Key Segment
GlobeNewswire Global Overview This article provides an overview of a market research report from GlobeNewswire. The Biologics CDMO market is projected to grow from $27.13 billion in 2026 to $38.29 billion by 2031, exhibiting a CAGR of 7.... -
Bristol Myers Squibb’s CELMoD Therapy ZENBEXUS™ Receives US FDA Accelerated Approval for Relapsed/Refractory Multiple Myeloma
Business Wire USA Overview Bristol Myers Squibb's novel CELMoD therapy, ZENBEXUS™ (iberdomide), has secured US FDA accelerated approval for relapsed or refractory multiple myeloma patients, including those at first relapse, in combinatio... -
XellSmart’s iPSC Parkinson’s Therapy XS411 Granted FDA Fast Track Designation, Accelerating Commercialization
Longevity.Technology UK Overview XellSmart's XS411, an allogeneic iPSC-derived cell therapy for Parkinson's disease, has received FDA Fast Track designation. This designation aims to expedite the development and review of therapies for s... -
Capricor Therapeutics’ GMP Facility Now Operational to Support Initial Commercial Launch of Deramiocel for Duchenne Muscular Dystrophy
Capricor Therapeutics USA Overview Capricor Therapeutics reported in its Q2 2026 financial results that its San Diego GMP manufacturing facility is operational to support the initial commercial launch of Deramiocel, an allogeneic cardiac... -
Commercial-Scale iPSC Cell Therapy: Advancements in Off-the-Shelf Treatments, Immunogenicity, and Cost Reduction are Key
The Medicine Maker UK Overview This article examines the challenges and technological advances in scaling induced pluripotent stem cell (iPSC) platforms for commercial cell therapies. It highlights the shift towards allogeneic, off-the-s... -
CNET Reviews 2026’s Latest Continuous Glucose Monitors (CGM), Highlighting FDA-Approved Dexcom Stelo’s Integration with Oura Ring
CNET USA Overview CNET's 2026 review of Continuous Glucose Monitors (CGM) features Abbott Freestyle Libre 2 and 3 Plus, Dexcom G7, and the notable Stelo by Dexcom, the first FDA-approved over-the-counter CGM in the US (2024). Stelo's sea... -
Rochester University’s Organ-on-a-Chip Adopted by FDA ISTAND Program to Predict Immunotherapy Toxicity, Reducing Animal Testing
The Debrief USA Overview Researchers at the University of Rochester have developed an organ-on-a-chip, the µSiM tissue chip, which has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot... -
Abbott Submits Dual Glucose-Ketone Sensor ‘Libre Duo’ to US FDA for DKA Prevention After European CE Mark
MedTech Dive USA Overview Abbott has filed an FDA application to launch its dual glucose-ketone sensor, Libre Duo, in the U.S. after receiving Europe's CE mark. Approval is expected by year-end, with the device aiming to prevent diabetic... -
Abingdon Health Showcases Future of POCT: Genalyte Merlin Runs 26 Tests in 30 Minutes, Oasis Diagnostics Offers Non-Invasive Saliva Systems
Abingdon Health UK Overview Abingdon Health announced innovations in next-generation Point-of-Care Diagnostics (POCT), highlighting Genalyte’s Merlin instrument, which received FDA clearance for a TSH assay in 2024 and can now perform up... -
FDA Releases Draft GDUFA/PDUFA Reauthorization Letters, Committing to Strengthen Cell and Gene Therapy Program and Leverage Real-World Evidence
Holland & Knight USA Overview The U.S. FDA has released draft commitment letters for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) and Prescription Drug User Fee Act (PDUFA). These letters include the FDA's commitme...
