Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and B. Braun Medical Inc., a global market leader in regional anesthesia and pain management, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision®, a breakthrough ultrasound guidance solution for real-time needle tip tracking.
Berubicin Previously Received FDA Orphan Drug Designation
The American Society of Pharmacovigilance (ASP) announced that the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Initiative has developed a collaborative community with participation by the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH).
Valencia Technologies Corporation ("Valencia"), a private medical device company, today announced the filing of its pre-market approval (PMA) application of its eCoin® Peripheral Neurostimulator System for overactive bladder with the Food and Drug Administration (FDA). e
VAPORESSO issued the following announcement on August 24.On August 20, 2020, VAPORESSO received the acceptance letter for the first round of its PMTA applications from the FDA - only three days after submission.
Following completion of the FDA review process at US Customs, Kiil is released for distribution
The U.S. Food and Drug Administration (FDA) is warning consumers about alcohol-based hand sanitizers that are being packaged in containers that may appear as food or drinks and may put consumers at risk of serious injury or death if ingested.
The U.S. Food and Drug Administration issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests.
LumiraDx, the next-generation point of care diagnostic company, announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the LumiraDx SARS-CoV-2 antigen test, which will help meet the global challenge of delivering fast and cost-efficient COVID-19 tests in community care settings.
Polaryx Therapeutics Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3) patients.
The National Industrial Hemp Council (NIHC) filed comments with the Food And Drug Administration (FDA) to help direct their work on establishing a policy of enforcement discretion on CBD products.
Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of glioblastoma, the most common and most aggressive form of primary brain
Romark, a research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's manufacturing facility in Manati, Puerto Rico for the production of ALINIA® (nitazoxanide) tablets, 500 mg and ALINIA® (nitazoxanide) for Oral Suspension, 100 mg/5mL in the U.S. market.
Isotopia Molecular Imaging is pleased to announce that it has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for no-carrier-added Lutetium-177 (n.c.a. Lu177), a medical radioisotope.
Indication expansion follows recent clearance for use in fractures of the pelvis, the clavicle, and small bones of the hand and foot
Fully transparent, anti-fog masks available to help healthcare providers and essential workers to protect themselves, communicate better, and ease confusion
RayBiotech Inc. issued the following announcement on August 17.Original source can be found here.
CytoSorbents Corporation (NASDAQ: CTSO) has entered into separate agreements with InvoSurg Inc. and Surgical Partners to commercialize CytoSorb® under its FDA Emergency Use Authorization (EUA) in adult, critically-ill, COVID-19 patients with imminent or confirmed respiratory failure.
Only authorized citrate-based replacement solution available in the U.S. for use in continuous renal replacement therapy (CRRT) during COVID-19 pandemic
The following is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response