The BLA was granted priority review, with a Prescription Drug User Fee Act (PDUFA) action date of 6 January 2023. Lecanemab was also previously granted fast track and breakthrough therapy designations by the FDA in December 2O21andJune 2021, respectively....
Approved by the U.S. Food and Drug Administration (FDA) in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic suppl...
Visit HSD atMD&M East, the east coast’s largest Medtech event taking place at theJacob K. Javits Convention CenterinNew York, NY. Booth #1470 More info Jun08-01 TOR ALDEN SPEAKING AT THE FIRST FDANEWS COMBINATION PRODUCT REGULATION CONFERENCE ...
On June 22, 2020, Dr. Kazem Kazempour, President & CEO, Amarex Taiwan, LLC and Dr. Chia-Hua Maggie Ho, COO of Amarex Taiwan, LLC gave a seminar to the Taiwan Food and Drug Administration (TFDA) titled U.S. FDA Approval Process for Digital Health Devices and Emergency Use Authorizations...
The article reports on the development in the U.S. drug sector. The approval of several drugs by the Food and Drug Administration (FDA) in the second quarter of 2011 is expected to alter treatment landscape in their respective disease indications. It involves the telaprevir and boceprevir for ...
Drug IndustryUnited StatesThe article focuses on the three new developed drugs subjected for approval of the U.S. Food and Drug Administration (FDA) for the second quarter (Q2) of 2014. Among the new drugs that were mentioned include ramucirumab for advanced gastric cancer treatment, ...
The article reports on the development in the U.S. drug sector. The approval of several drugs by the Food and Drug Administration (FDA) in the second quarter of 2011 is expected to alter treatment landscape in their respective disease indications. It involves the telaprevir and boceprevir for ...
or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability ...
s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi™ is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to...
Beyond NXP900, Nuvectis is also preparing for an important data readout for NXP800, in platinum resistant, ARID1a-mutated ovarian cancer. NXP800, which has received FDA Orphan Drug and Fast Track designations, has shown encouraging preclinical efficacy in both platinum-sensitive and resistant A...