Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
Inspection included drug device combinations covering our recent filing in nasal sprays domain
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates
Immunology remained AbbVie’s largest and fastest-growing segment, delivering $30.41 billion in global net revenues,
US revenue increased 43% to $12.9 billion, fueled by a 50% jump in volume, partially offset by a 7% decline in realized prices
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
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