The U.S. Food and Drug Administration issued the final guidance, “Breast Implants - Certain Labeling Recommendations to Improve Patient Communication,” as part of the agency’s effort to help improve the information available to patients and health care professionals about the risks of breast implants.
The United States Department of Agriculture (USDA) and the United States Food and Drug Administration (FDA) signed a Memorandum of Understanding (MOU) outlining strengthened coordination between the FDA and the USDA’s Agricultural Marketing Service (AMS) and Foreign Agricultural Service (FAS) to facilitate the export of milk and milk products from the United States. U.S. dairy exports are valued at nearly $6 billion annually.
Stemedica Cell Technologies, Inc. has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) approval for "A Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Preliminary Efficacy of Intravenous Allogeneic Mesenchymal Stem Cells in Patients with Moderate to Severe Lung Injury due to COVID-19."
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold.
SentiAR, a pioneer in visualization technologies for surgical applications announces U.S. Food and Drug Administration (FDA) 510(k) clearance of its groundbreaking CommandEP™ system, the first holographic guidance system to be used during an invasive cardiac procedure.
GI Windows Medical Corp, a clinical-stage, privately-held medical device company pioneering new advancements in anastomosis technology announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the self-forming magnetic compression anastomosis device indicated for small bowel end to end anastomosis for ileostomy reversal or tissue resection.
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).
The Access Interleukin-6 (IL-6) assay is designed to assist physicians in the identification of severe inflammatory response in COVID-19 patients
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.
2nd Investigational Gene Therapy in Clinic, Potential 3rd Therapy in PKU Franchise, 15+ Year Commitment to PKU Community
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
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.
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.
Automated, dual antigen serological testing for SARS-CoV-2 IgG antibodies now EUA approved and ready to ship!
WAKIX is the first and only non-scheduled treatment approved for excessive daytime sleepiness or cataplexy in adult patients with narcolepsy
World's Simplest High Throughput RT-PCR Test for COVID-19 has the potential to increase testing capacity by millions per week
RLF-100™ therapy associated with a 9-fold increased probability of survival and recovery from respiratory failure in an open-label, prospective study
First compound from pipeline of six early-stage oncology programs to advance into clinical development-
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).
Personalized digital surgery platform can simulate surgery and print 3D surgical splints and guides for the operating room