Tag: US Food and Drug Administration

May 19, 2019

5 Top Weekly NASDAQ Biotech and Pharma Stocks: Index in Green

Last week's top NASDAQ biotech and pharma stocks were Harrow Health, Sesen Bio, Zynerba Pharmaceuticals, Athersys and Catalyst Pharmaceuticals.
May 17, 2019

Agile Therapeutics Resubmits New Drug Application (NDA) for its Transdermal Low-Dose Contraceptive Patch,

Agile Therapeutics (NASDAQ:AGRX) has announced it has resubmitted to the US Food and Drug Administration (FDA) its new drug application...
May 16, 2019

Cue Biopharma Announces FDA Acceptance of IND for Lead Immuno-oncology Candidate CUE-101

Cue Biopharma (NASDAQ:CUE) has announced that the US Food and Drug Administration (FDA) has accepted Cue Biopharma’s investigational new drug...
May 16, 2019

Adverum Biotechnologies Provides Update on OPTIC Phase 1 Trial for ADVM-022

Adverum Biotechnologies (NASDAQ:ADVM) has announced that the US Food and Drug Administration (FDA) has removed the clinical hold on the...
May 15, 2019

Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug Application

Turning Point Therapeutics (NASDAQ:TPTX) has announced it has received clearance from the US Food and Drug Administration (FDA) for its...
May 14, 2019

Homology Medicines Announces FDA Fast Track Designation for HMI-102 Gene Therapy Development Candidate

Homology Medicines (NASDAQ:FIXX) has announced that the US Food and Drug Administration (FDA) has given it Fast Track designation for...
May 13, 2019

VIDEO — Aptose Biosciences CEO: Clinical Programs in the Works

William Rice of Aptose Biosciences discusses the company's two clinical programs and a drug candidate in the discovery stage.