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FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease
Eisai and Biogen announced today that the US Food and Drug Administration (FDA) has accepted […]
Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of Stargardt Disease
Nanoscope Therapeutics, a clinical-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced […]
TTP Introduces Cellular Origins, a TTP Company Focussed on Delivering Scalable Manufacture of Cell and Gene Therapies
TTP, a leading independent technology and product development company, has today announced the launch of […]
Autolomous to Provide Digital Solutions to Center for Breakthrough Medicines to Streamline and Automate Manufacturing of Cell & Gene Therapies
Autolomous LTD, the market-leading developer of critical manufacturing management systems for Cell and Gene Therapies (CGT), has announced […]
- Axel Hoos, MD, PhD, Joins NextPoint Therapeutics Board of Directors Read more
- Coya Therapeutics Announces Positive Results from a Proof-of-Concept Academic Clinical Study for COYA 302 in Amyotrophic Lateral Sclerosis (ALS) Read more
- BeiGene Enters New Phase to Expand US Manufacturing and R&D Footprint in New Jersey Read more
- Mindset Health Raises $12M to Expand Digital Hypnotherapy Apps & Scale Distribution Read more
- GeneDx Announces Progress on GUARDIAN Study and Promise of Early Genomic Testing to End Rare Disease “Diagnostic Odyssey” Read more