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The FDA ( U.S. Food and Drug Administration ) has approved Reyvow ( Lasmiditan ) tablets for the acute treatment of migraine with or without aura ( a sensory phenomenon or visual disturbance ) in adul ...


The FDA ( U.S. Food and Drug Administration ) has approved Ofev ( Nintedanib ) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with syste ...


The FDA ( U.S. Food and Drug Administration ) has expanded the approval of Mavyret ( Glecaprevir and Pibrentasvir ) tablets for an eight-week duration for the treatment of adults and children ages 12 ...


The European Commission has granted marketing authorization in the European Union ( EU ) for the precision oncology treatment Vitrakvi ( Larotrectinib ). The drug is indicated for the treatment of a ...


The European Commission ( EC ) has granted marketing authorisation for Erleada ( Apalutamide ), a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastat ...


The FDA ( U.S. Food and Drug Administration ) has announced Project Orbis, an initiative of the FDA Oncology Center of Excellence ( OCE ). Project Orbis provides a framework for concurrent submissio ...


The European Commission ( EC ) has approved Empliciti ( Elotuzumab ) plus Pomalidomide and low-dose Dexamethasone ( EPd ) for the treatment of adult patients with relapsed and refractory multiple myel ...


The Food and Drug Administration ( FDA ) has approved Nubeqa ( Darolutamide ) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS, a multicenter, double-blind, pla ...


The European Commission has approved Tecentriq ( Atezolizumab ) plus chemotherapy ( Abraxane [ Paclitaxel protein-bound particles for injectable suspension ( albumin-bound ); nab-Paclitaxel ] ) for th ...


The FDA ( Food and Drug Administration ) has granted accelerated approval to Xpovio ( Selinexor ) in combination with Dexamethasone for adult patients with relapsed or refractory multiple myeloma ( RR ...


The FDA ( Food and Drug Administration ) has approved Inrebic ( Fedratinib ) for adults with intermediate-2 or high-risk primary or secondary ( post-polycythemia vera or post-essential thrombocythemia ...


The FDA ( U.S. Food and Drug Administration ) has approved Rinvoq ( Upadacitinib ), a 15 mg, once-daily oral Janus kinase ( JAK ) inhibitor, for the treatment of adults with moderately to severely act ...


The FDA ( U.S. Food and Drug Administration ) has approved Emgality ( Galcanezumab-gnlm; Galcanezumab ) solution for injection for the treatment of episodic cluster headache in adults. Cluster hea ...


The FDA ( U.S. Food and Drug Administration ) has granted accelerated approval to Rozlytrek ( Entrectinib ), a treatment for adult and adolescent patients whose cancers have the specific genetic defec ...


The FDA ( U.S. Food and Drug Administration ) has granted approval to Turalio ( Pexidartinib ) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor ( TGCT ) asso ...