Drug Approval | February 05, 2026
Strides Pharma Inc receives USFDA closure report for Chestnut Ridge formulations facility
Inspection included drug device combinations covering our recent filing in nasal sprays domain
Inspection included drug device combinations covering our recent filing in nasal sprays domain
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,
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available
The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization
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
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
Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs
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