Koselugo (selumetinib) was largely forgotten after failing Phase III trials in thyroid and lung cancer, as well as uveal melanoma, but its approval in Europe for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1, which follows a US approval for the rare condition last year, has breathed new life into the once-lauded MEK 1/2 inhibitor.
Another milestone in the successful oncology collaboration between AstraZeneca PLC and Merck & Co., Inc. has been reached with approval in Europe granted to Koselugo, the firm's therapy for neurofibromatosis type 1 (NF1), a rare debilitating genetic condition.
Two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Commission...
MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.
The biotech announced results from the pivotal trial of isaralgagene civoparvovec and plans to file for approval in 2026 as it looks for a commercialization partner.
More than a dozen vaccines for infectious diseases are in Phase III development across the industry, as the US regulatory environment brings increased uncertainty.
