PHILADELPHIA, March 18, 2026--iECURE, Inc., a clinical-stage genome editing company developing variant-agnostic in vivo ...
Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...
SARASOTA, FL, July 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and ...
In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine. Can you explain what global harmonization of regulatory CMC entails and ...
Clinical efficacy top-line results of PARADIGM, a Phase 2b trial in ALS, expected in December 2023 CAMBRIDGE, Mass., Nov. 13, 2023 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NRSN) ("NeuroSense"), a ...
IMUNON announced FDA alignment on CMC strategy for IMNN-001, preparing for a Phase 3 trial in advanced ovarian cancer. IMUNON, Inc. announced a successful Type C Chemistry, Manufacturing, and Controls ...
In 2026, the global regulatory framework for cell-based therapies continues to evolve, placing increased emphasis on robust CMC control strategies, comparability planning, and lifecycle management. As ...
DifGen Pharmaceuticals and Aveva Drug Delivery Systems today announced a strategic platform collaboration with Biostax Corp d/b/a Attune Biotech, SGP Holdings, and Callan JMB to lead U.S.-based ...
Breakthrough Therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in cardiac biomarkers and functional measures LX2006 also selected for ...
Christine Allen, CEO and Co-Founder of Intrepid Labs, and Andy Lewis, CSO at Quotient Sciences, highlight their strategic ...
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