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Pharma News and Updates for Sarepta, Astellas, SiSaf, ImmPACT Bio, Otsuka, CytoAgents, Lundbeck
Sarepta Therapeutics’s SRP-9001 Gene Therapy; FDA Approves Astellas’ VEOZAH; FDA Orphan Drug Designation and Rare Pediatric Disease Designation to SiSaf’s siRNA Therapy SIS-101-ADO; FDA Grants Fast Track Designation to IMPT-314; FDA Approves First Drug for Agitation in People With Alzheimer’s Disease; FDA Accepted the CytoAgents’ IND Application for CTO1681

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy Sarepta Therapeutics, Inc., a pioneer in precision genetic medicine for rare diseases, announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in favor of...

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Entasis
CAR-T Phase I trials; ContraVir Announces; Merck acquired; Excision BioTherapeutics bags $10M

Two ongoing CAR-T Phase I trials of Cellectis drug candidate has been put on hold by FDA after a patient’s death FDA has put two CAR-T trials on hold following a patient’s death, less than a week after the first ever CAR-T was approved by the US regulatory agency.  The patient (78) was suffering from r...

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