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MEDICAL DEVICE NEWS MAGAZINE

FDA Updates

Avacta Announces FDA Approval of its Investigational New Drug (IND) Application for AVA6000

Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™...

U.S. FDA Approves Nova Mentis Orphan Drug Application

Dr. Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board said, "The U.S. FDA has issued guidance concerning the usage of observational clinical study Real-World Evidence (RWE) to support the potential benefits of a medical product. NOVA intends to immediately launch an IRB approved ASD observational study to provide baseline clinical biomarker RWE data in support of its psilocybin IND to treat FXS."  

Anitoa Receives FDA Registration and Class II Exempt Device Listing for its Maverick Line of Portable qPCR Instruments

Dr. Zhimin Ding, CEO of Anitoa Systems said, "We believe our portable qPCR instruments and the software solutions offer features that meet the needs of customers seeking highly sensitive detection of key life-threatening pathogens while being extremely cost-effective."

Stealth BioTherapeutics Receives Refusal to File Letter from the FDA

Elamipretide was previously granted rare pediatric designation, fast track designation, and orphan drug designation by the FDA, and orphan drug designation by the European Medicines Agency (EMA), for the treatment of Barth syndrome. 

OpGen Receives FDA Clearance for Acuitas® AMR Gene Panel

The Acuitas® AMR Gene Panel detects 28 genetic antimicrobial resistance (AMR) markers in isolated bacterial colonies from 26 different pathogens.

FDA Issues Draft Guidance on Donor Eligibility and Manufacturing of Cellular Therapies for Animals

"The FDA is seeking to improve transparency by engaging early in the development process and informing industry of our draft recommendations now, while the industry is still taking shape, as we are receiving applications seeking approval of ACTPs for use in animals," said Dr. Steven Solomon, director of the FDA's Center for Veterinary Medicine.

Co-Diagnostics JV CoSara Receives Clearance from Indian FDA for Chikungunya and Dengue Tests

The Saragene test kits approved by the CDSCO use the Company's patented CoPrimer™ technology for the qualitative detection of these mosquito-borne viruses.

FDA Clears Promega OncoMate™ MSI Dx Analysis System

Oncologists and pathologists in US can now use microsatellite instability (MSI) diagnostic to screen for Lynch syndrome in patients with colorectal cancer.