Tag: US Food and Drug Administration

September 17, 2018

FDA Grants Rare Pediatric Disease Designation to Cellectar Biosciences’ CLR 131 for the Treatment of Osteosarcoma

Cellectar Biosciences (Nasdaq:CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of...
September 14, 2018

Cannabis Weekly Round-Up: Cannabis Collection Set to Debut in Canada

The Investing News Network rounds up some of the biggest company and market news in the cannabis market for the...
September 13, 2018

Motus GI Receives FDA Clearance for Colonoscopy Product

Motus announced on Thursday that its FDA-cleared Pure-Vu Slim Sleeve, which is an extension of its standard Pure-Vu System, will...
September 12, 2018

U.S. FDA Assigns PDUFA Date to Portola Pharmaceuticals’ Prior Approval Supplement for the Large-Scale Generation 2 Andexxa Process

Portola Pharmaceuticals (Nasdaq:PTLA) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Company’s Prior Approval Supplement...
September 11, 2018

Viveve Submits Investigational Device Exemption to FDA to Conduct LIBERATE-U.S. Trial for Improvement of Stress Urinary Incontinence

Viveve Medical (NASDAQ:VIVE), a medical technology company focused on women’s intimate health, today announced submission of an Investigational Device Exemption...
September 10, 2018

Amicus Therapeutics Announces Regulatory and Clinical Updates for AT-GAA in Pompe Disease

Amicus Therapeutics (Nasdaq:FOLD), a global biotechnology company focused on discovering, developing and delivering novel medicines for rare metabolic diseases, announced...
September 7, 2018

IRIDEX Announces FDA Clearance to Introduce Updated TruFocus LIO Premiere Laser Accessory to the U.S. Market

IRIDEX Corporation (Nasdaq:IRIX) the introduction of its updated TruFocus LIO Premiere laser accessory following U.S. Food and Drug Administration (FDA)...
September 5, 2018

ProQR’s Share Price Soars with Positive Interim Results

Shares of the company spiked 120.75 percent on Wednesday on the back of a Phase 1/2 clinical trial of QR-110...
September 5, 2018

Dermira Provides Launch Readiness Update for QBREXZA (glycopyrronium) Cloth for Primary Axillary Hyperhidrosis

Dermira (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the...
September 5, 2018

Fibrocell Announces FDA Fast Track Designation of FCX-013 for Treatment of Moderate to Severe Localized Scleroderma

Fibrocell Science (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today...