Boehringer Ingelheim announces the FDA has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA’s Fast Track designation enables development of new therapies that treat serious conditions and fulfil an unmet medical need in an effort to get treatments to those in need sooner.
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US regulators will conduct a priority review of MSD’s Keytruda to treat patients with advanced cervical cancer. The company is seeking approval for the drug’s use in patients with cervical cancer who experience disease progression during or post chemotherapy. The FDA’s decision marks the first filing acceptance and priority review issued for an anti-PD-1 therapy
The US regulators have approved a label update to BMS’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks. The company says the approval will allow physicians to customise patient care with the option of using the new dose of 480mg every four weeks in addition to the previously available