R&D | December 12, 2025
OTR Therapeutics and Zealand Pharma join forces to target metabolic diseases
The companies aim to expand treatment options for millions living with metabolic disorders
The companies aim to expand treatment options for millions living with metabolic disorders
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The company had achieved the highest "A" rating in Climate Change
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The company will respond to the US FDA within the stipulated timelines
Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
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