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Helsinn Announces FDA Acceptance of IND Application

Helsinn Announces FDA Acceptance of IND Application

Lugano, Switzerland, June 8 (Korea Bizwire) - Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare diseases products, today announced that on April 1, 2020 the U.S. Food and Drug Administration (FDA) completed the review of the Investigational New Drug (IND) application for TAS0953/HM06 and released a “Study May Proceed” letter for [...]

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

Amarex, an NSF International Company, Executes Five Rush COVID-19 Related Submissions to the FDA

Ann Arbor, Mich., USA, April 2 (Korea Bizwire) — In early March 2020, Amarex Clinical Research LLC, an NSF International company, executed a rush submission of an emergency use Investigational New Drug (IND) application to add COVID-19 as a new indication for CytoDyn’s monoclonal antibody product, Leronlimab. The product is currently being tested for HIV [...]