FDA's review of filing for osteoporosis abaloparatide delayed by three months to June 30, bringing it closer to the action date for Amgen's competing anabolic agent romosuzumab, which has an action date of July 19.
Radius Health Inc. announced that FDA has extended the user fee date for its anabolic osteoporosis drug abaloparatide from March 30 to June 30, soon after the company discussed extensive plans for launch with no mention of a regulatory delay.
FDA needs more time to review the NDA for the daily subcutaneous formulation in postmenopausal osteoporosis "to allow time to...
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Swiss major confident that new oncology drugs will fill revenue gap.
Stelara revenues declined 42.7% in the quarter due to biosimilars, but innovative medicines grew 4.9%, surpassing $15bn for the quarter. Although pharma tariffs could be coming, the firm said the impact continues to be hard to predict.
Sun’s Leqselvi goes up against Lilly's Olumiant and Pfizer's Litfulo, which currently has the broadest label, in the US alopecia market. Can it shake things up early, amid growing activity in the space with several new mechanisms of action being investigated?
Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.
Reimbursement rules are disincentivizing innovation, according to Vas Narasimhan.
Recent moves in the industry include changes at the top at Ascentage Pharma, Inventiva and Brenig Therapeutics, plus five companies get new CFOs.
As AI-driven firms like Insilico, big pharma like J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s respectively advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?
