Tag: Investigational New Drug

US Drugmakers Support FDA Steps Aimed at Facilitating Access to Investigational Drugs

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A new report from the Government Accountability Office (GAO) finds that drugmakers and other stakeholders are largely supportive of steps taken by the US Food and Drug Administration (FDA) to facilita...

Regeneron Pharmaceuticals Announced Positive Pivotal Phase 3 Results for Evinacumab

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Regeneron Pharmaceuticals, Inc. announced positive pivotal Phase 3 results for evinacumab, an investigational angiopoietin-like 3 (ANGPTL3) antibody, in patients with homozygous familial hypercholeste...

ViiV Healthcare Submits Regulatory Application to EMA for Investigational Cabotegravir

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ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced the submission of a marketing authorisation applicati...

FDA Predicts Rapid Development of Cell and Gene Therapies

A massive upsurge in the development of cell and gene therapies means the FDA expects to receive up to 200 applications to start trials every year from 2020. It also expects to be approving 10 to 2...

FDA Recommendations for Submitting Human Gene Therapeutic IND Application

Human therapeutics include all products that transmit and unfold their effect through transcription or translation of transferred genetic material or through targeted modification of host/human gene s...

FDA Cleared the IND Application of BBT-877

Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the Investigational New Drug (I...