The inspection concluded with one minor observation in Form 483
The positive CHMP opinion is supported by results from the Phase III QUASAR trial
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
Retatrutide, tested at 9 mg and 12 mg doses alongside diet and exercise, met all primary and key secondary endpoints
The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034
The companies aim to expand treatment options for millions living with metabolic disorders
Dr. Reddy's commits to achieving Net Zero greenhouse gas emissions across its value chain by FY 2045
The product will be marketed by Dr. Reddy's Laboratories Inc.
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
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