In the News
Web Exclusives | February 11, 2020
Pivotal phase 3 data demonstrated treatment with luspatercept resulted in statistically significant increased red blood cell transfusion independence compared with placebo.
Web Exclusives | February 4, 2020
On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020.
Web Exclusives | January 13, 2020
The FDA approval of avapritinib marks the first time a drug has been approved specifically for patients with GIST harboring PDGFRA exon 18 mutations, which are involved in approximately 10% of GIST cases.
Web Exclusives | December 16, 2019
On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.
Web Exclusives | December 11, 2019
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug designation to the agent for the treatment of soft tissue sarcomas.
Web Exclusives | November 25, 2019
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.
Web Exclusives | November 18, 2019
- Teva Will Resume Production of Vincristine in Response to Shortage
- FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
- FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma
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Results 1 - 10 of 37
Results 1 - 10 of 37