Drug Approval | March 13, 2026
Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Marks significant milestone for breakthrough biologic to treat rare blood cancers
Marks significant milestone for breakthrough biologic to treat rare blood cancers
The collaboration will leverage this clinical experience to inform NCEL-101 development, streamline regulatory pathways, and potentially accelerate timelines for achieving durable graft survival comparable to donor human islets
The initiative provides clearer regulatory guidance and a defined path from research in space to patient access on Earth
The two companies will collaborate to evaluate Hopewell’s ttLNPs for clinical applications
The document, published under the Accelerating Clinical Trials in the EU (ACT EU) initiative, sets out how trials should be conducted when health emergencies disrupt normal research operations
The licensed intellectual property covers methods and designs for CAR constructs engineered to function in myeloid cell populations
The Silver Medal recognizes strong performance across sustainability, ethics, environment, labour & human rights, and responsible procurement
The funding will be spread over four years, with BXLS also eligible for regulatory and commercial milestones, plus royalties on worldwide sales
Achondroplasia, a rare genetic disorder, causes skeletal dysplasia and often increases the risk of muscular, neurological, and cardiorespiratory complications
Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans
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