Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
This collaboration aims to bridge India’s talent and translational gap in this rapidly growing field by equipping professionals with practical expertise in the manufacturing of advanced therapies.
Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
ART-123 is a recombinant human thrombomodulin approved in Japan in 2008
Label updates reflect growing body of real-world evidence and regulatory confidence in the safety profile of the class of CD19- and BCMA-directed autologous CAR T cell therapies, reinforcing efforts to increase equitable access
Facility also named 2025 ISPE Facility of the Year Winner for Social Impact - Unmet Medical Needs
Launched in Thailand, the ASEAN hub, marking an early entry into the fast-growing combination therapy market (DPP-4 and SGLT-2 inhibitor combination) with strong potential for market leadership
DESTINY-Breast09 Phase III trial of AstraZeneca and Daiichi Sankyo’s Enhertu is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2-positive metastatic patient population versus current 1st-line standard of care
Anushree has been with Abbott since 2021 and currently serving as Head of Strategy and Portfolio
Subscribe To Our Newsletter & Stay Updated