Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
New Tracxn report highlights growing investor confidence in automated cell therapy production, with Cellares and Ori Biotech dominating funding and regulatory milestones
Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)
Expanded indication makes Stelo the first FDA-cleared OTC CGM for children aged two years and older with diabetes or prediabetes
The decision was driven by results from the Phase III CAPItello-281 trial,
MeRT becomes one of the few FDA-cleared neuromodulation therapies for PTSD, using EEG biomarkers and AI to personalize treatment for patients with treatment-resistant symptoms
The move makes EBGLYSS the only therapy offering as few as six maintenance injections per year
The approved product is therapeutically equivalent to Haldol tablets of Ortho McNeil Pharmaceutical
This facility plays an important role in Granules’ global manufacturing and supply network
First immunotherapy combination approved in the US for BCG-naïve high-risk NMIBC demonstrates a 32% reduction in the risk of disease recurrence, progression, or death
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