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AIDOC: Granted AI industry-first FDA clearance for triage of incidental pulmonary embolism

This is the company's 6th FDA clearance and further solidifies its leadership as the most comprehensive acute AI vendor in the market

TYBER MEDICAL: Receives FDA Clearance on Foot and Ankle Plating Systems

Comprehensive portfolio is the first of several planned plating releases for the distal extremities

ASTELLAS PHARMA INC.: U.S. FDA Grants Fast Track Designation for ASP0367/MA-0211, a Selective PPARδ Modulator being Developed for the Treatment of Primary Mitochondrial Myopathies

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP0367/MA-0211 ("ASP0367") as a potential treatment for primary mitochondrial myopathies (PMM).

EZRA: Receives FDA Clearance for Prostate Cancer Artificial Intelligence

Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI

FRESENIUS MEDICAL CARE: FDA Approves New Container System for Peritoneal Dialysis Solutions

Fresenius Medical Care North America Announces Next Generation Solution Bags to Support Continued Home Dialysis Expansion

ONCOPEPTIDES: Has submitted an Investigational New Drug application to FDA for the second drug candidate from the PDC platform

Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC).

ALKERMES: FDA Advisory Committee Votes in Support of ALKS 3831 for the Treatment of Schizophrenia and Bipolar I Disorder

Alkermes plc (Nasdaq: ALKS) announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA).

BIOGX: Announces FDA Emergency Use Authorization Submission of Extraction-Free Direct RT-PCR Test for COVID-19

World's Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week

HARMONY BIOSCIENCES: Receives FDA Approval For Expanded Use Of WAKIX® (pitolisant) For The Treatment Of Cataplexy In Adult Patients With Narcolepsy

WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy

AJINOMOTO BIO-PHARMA SERVICES: First Commercial Drug Manufactured via Ajinomoto Bio-Pharma Services' AJIPHASE Technology Receives FDA Approval

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce that the US FDA has approved the first commercial drug manufactured via Aji Bio-Pharma's proprietary AJIPHASE® production process.

ZEUS SCIENTIFIC: Announces FDA EUA Approval for ZEUS ELISA™ SARS-CoV-2 IgG Test System

Automated, dual antigen serological testing for SARS-CoV-2 IgG antibodies now EUA approved and ready to ship!

HAEMONETICS: Receives FDA Clearance For NexSys PCS® With Persona™ Technology

Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative hematology solutions to drive better patient outcomes, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its NexSys PCS® system with Persona™ technology.

BD: Granted FDA 510(k) Clearance for BD FACSLyric™ Flow Cytometer with Newly Integrated BD FACSDuet™ Sample Preparation System

BD FACSDuet™ Sample Preparation System, now available in the U.S., as the first fully automated sample-to-answer solution when integrated with the BD FACSLyric™ Flow Cytometer

BIOMARIN: Pioneer in Phenylketonuria (PKU) and Gene Therapy, Receives FDA Fast Track Designation for PKU Investigational Gene Therapy, BMN 307

2nd Investigational Gene Therapy in Clinic, Potential 3rd Therapy in PKU Franchise, 15+ Year Commitment to PKU Community

MCRA: CRO Assists Simplify Medical, Inc. on the Fastest Spine PMA Ever Approved by the FDA

MCRA's CRO assisted Simplify Medical with the management of the clinical study, including leading data management, Clinical Events Committee (CEC), and monitoring support for the successful PMA approval.

BECKMAN COULTER DIAGNOSTICS: FDA Emergency Use Authorization awarded to the Beckman Coulter Access IL-6 test

The Access Interleukin-6 (IL-6) assay is designed to assist physicians in the identification of severe inflammatory response in COVID-19 patients

PAOG: Announces New Engagement To Prepare For Investigational New Drug Application With FDA

Announced engaging Saul Kaye the founder of iCAN (www.israel-cannabis.com) and CannaTech (www.canna-tech.co) to provide an independent review of PAOG's RespRx research for the treatment of Chronic Obstructive Pulmonary Disease (COPD), and to help prepare RexpRx for engaging with a contract research organization (CRO) to advance an investigational New Drug application (IND) with the Food and Drug Administration (FDA).

FDA Reporter