This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets
Under the agreement, Apotex’s branded division, Searchlight Pharma, will seek regulatory approval and handle marketing and distribution in Canada
Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
Inspection included drug device combinations covering our recent filing in nasal sprays domain
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
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