Drug Approval | September 12, 2021
US FDA grants Soligenix Orphan Drug Designation for the treatment of T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
Extension of hypericin orphan designation beyond cutaneous T-cell lymphoma
The projected business potential is around US$ 1 million in the first year
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
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
Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies
Globally, BRUKINSA is approved in more than 70 countries
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
Approval is based on positive data from the Phase 3 ECHELON-3 trial
New Jersey-based manufacturing site to support innovative decentralized approach for improved patient experience
Mankind Pharma will have exclusive rights to register, import, market, sell and distribute sintilimab in India
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