Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
Efzimfotase alfa is an investigational enzyme replacement therapy designed to reduce injection volume
The decision is based on the phase 3 DESTINY-Breast11 trial
Industry leaders highlighted the pharmaceutical sector’s role in advancing research, innovation, early screening, and multi-stakeholder collaboration
Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population
The study is a collaboration between AIM, AstraZeneca, and Erasmus Medical Center in the Netherlands
The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy
Over a two-decade career, Dr. Berman has worked on more than a dozen clinical-stage immunotherapies, including senior leadership roles in developing four oncology biologics
SLE remains a life-threatening autoimmune disease, with patients facing an elevated risk of early mortality and long-term organ damage
Heart failure affects an estimated 64.3 million people worldwide
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