Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals
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
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization
The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites
The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses
N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway
As CRISPR and prime editing applications advance, researchers increasingly rely on longer guide RNAs to boost editing efficiency and reduce off-target effects
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases
This achievement validates global demand and catapults Wanbury into high-growth acceleration
Glucon-D maintained its leadership position with a 59% MAT market share
NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration
Nine-month revenue grew 17.5% to Rs 76,277 lakh, EBITDA climbed to Rs 15,981 lakh, and net profit reached Rs 8,200 lakh
TB Alliance will continue to lead clinical development, while Lupin will leverage its global manufacturing, regulatory, and supply chain expertise to ensure the drug reaches patients worldwide
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