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FDA Finalizes New Nutrition Facts Panel

2016-06-06 04:56:00| Food Processing

New label includes "added sugars," enlarges serving sizes but removes calories from fat.

H3 Biomedicine Receives FDA Acceptance For Investigational New Drug Application

2016-06-01 06:06:14| drugdiscoveryonline Home Page

H3 Biomedicine Inc., a biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of the Eisai Group, announced recently that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application to begin Phase 1 clinical trials for its lead oncology drug candidate H3B-8800

Tags: application drug acceptance receives

FDA Grants QIDP And Fast Track Designation To CD101 Topical, Cidara Therapeutics' Novel Antifungal Product Candidate

2016-06-01 05:41:19| drugdiscoveryonline Home Page

Cidara Therapeutics, Inc., a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, recently announced that the U.S. Food and Drug Administration (FDA) has designated the company’s novel antifungal product candidate, CD101 topical, as a Qualified Infectious Disease Product (QIDP), with Fast Track status for its development program

Tags: product fast track candidate

Syros Pharmaceuticals Announces FDA Acceptance Of IND To Advance SY-1425 Into Phase 2 Clinical Trial

2016-06-01 04:49:19| drugdiscoveryonline Home Page

Syros Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application to advance its lead drug candidate, SY-1425, a potent and selective retinoic acid receptor alpha (RARα) agonist, into a Phase 2 clinical trial in genomically defined subsets of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed high-risk myelodysplastic syndrome (MDS) identified through its platform

Tags: trial advance phase acceptance