The U.S. Food and Drug Administration accepted Jazz Pharmaceuticals and Spain-based PharmaMar’s New Drug Application for lurbinectedin under Priority Review.
The U.S. Food and Drug Administration granted Priority Review to Deciphera Pharmaceuticals’ ripretinib as an investigational treatment for advanced gastrointestinal stromal tumors (GIST).
Astex Pharmaceuticals Inc. announced that the U.S. FDA accepted for Priority Review the company’s NDA for oral C-DEC (cedazuridine and decitabine) as a treatment for adults with previously untreated intermediate- and high-risk myelodysplastic syndromes, including chronic myelomonocytic leukemia.
Novartis won fast-track U.S. regulatory review for capmatinib (INC280) in a hard-to-treat form of lung cancer, the Swiss drugmaker said on Tuesday.
Emeryville, California-based Zogenix announced positive topline data from the company’s Phase III trial of Fintepla (fenfluramine) in Lennox-Gastaut Syndrome.
Genentech’s Risdiplam showed significant improvement in motor function in people aged 2-25 who have been diagnosed with Type 2 or 3 spinal muscular atrophy.
Although January 2020 was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
Bristol-Myers Squibb withdrew the company’s application in the European Union for the combination of Opdivo and Yervoy for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227.
The U.S. Food and Drug Administration regulatory body accepted for priority review the use of Sanofi and Regeneron’s Dupixent product for children aged 6-11 with moderate-to-severe eczema,
Ireland’s Horizon Therapeutics became the first to win regulatory approval in the United States for the treatment of Thyroid Eye Disease (TED), a progressive autoimmune disorder that can threaten the vision of those afflicted.