RAYBIOTECH: Seeks Authorization from FDA for 1-step COVID-19 PCR Detection in Saliva
RayBiotech Inc. issued the following announcement on August 17.Original source can be found here.
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CLEARMASK: Receives FDA clearance for world's first fully transparent surgical mask
Fully transparent, anti-fog masks available to help healthcare providers and essential workers to protect themselves, communicate better, and ease confusion
ILLUMINOSS MEDICAL: Receives FDA Clearance for Use in Fibula Fractures
Indication expansion follows recent clearance for use in fractures of the pelvis, the clavicle, and small bones of the hand and foot
ISOTOPIA MOLECULAR IMAGING: Files Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for Lu n.c.a.
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.
ROMARK: Announces FDA Approval Of New Manufacturing Facility In Manati, Puerto Rico
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.
KAZIA THERAPEUTICS LTD: US FDA Awards Fast Track Designation (FTD) to Paxalisib for Glioblastoma
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
NIHC: Delivers Specific Recommendations for FDA to Regulate CBD
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.
POLARYX THERAPEUTICS: Receives FDA Fast Track Designation to PLX-200 for the Treatment of Patients With Juvenile Neuronal Ceroid Lipofuscinosis
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.
LUMIRADX: Receives FDA Emergency Use Authorization for Point of Care COVID-19 Antigen Test
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.
FDA: Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card
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.
FDA: Warns Consumers About Hand Sanitizer Packaged in Food and Drink Containers
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.
HAWKEYE SYSTEMS: Sanitizer Product Released by FDA for US Entry
Following completion of the FDA review process at US Customs, Kiil is released for distribution
VAPORESSO: First-round PMTA applications were accepted by FDA
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.
VALENCIA TECHNOLOGIES: Files Pre-Market Approval (PMA) Application with U.S. FDA for eCoin® Peripheral Neurostimulator
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
AMERICAN SOCIETY OF PHARMACOVIGILANCE: FDA Becomes a Member of STRIPE, New Collaborative Community to Help Advance Pharmacogenomics (PGx) into Clinical Practice
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).
CNS: Provides FDA Update on IND Filing
Berubicin Previously Received FDA Orphan Drug Designation
PHILIPS AND B. BRAUN: Receive FDA clearance for breakthrough Onvision® Needle Tip Tracking technology for regional anesthesia
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.
JOINTECHLABS: FDA Clears Jointechlabs' MiniTC for Point-of-Care Fat Tissue Processing and its Broad Range of Applications
Jointechlabs – a leader in point-of-care regenerative medicine therapies – announced that the U.S. Food and Drug Administration (FDA) cleared the company's MiniTC™ for point-of-care fat tissue processing designed to obtain microfat (or fat grafts), for multiple indications.
FDA: Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines
The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19.
FDA: Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D., acting director, Center for Drug Evaluation and Research