LUMINEX: Receives FDA Emergency Use Authorization for COVID-19 Antibody Test
xMAP SARS-CoV-2 Multi-Antigen IgG Assay is enabled by xMAP Technology, the gold standard for multiplexing serologic testing
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CYTRX CORPORATION: Highlights Orphazyme's Completion of Rolling Submission of its New Drug Application with the U.S. FDA for Arimoclomol in Niemann-Pick Disease Type-C
Orphazyme expects to submit MAA for arimoclomol for NPC to European Medicines Agency in the second half of 2020
ORALDNA LABS: FDA Issues EUA for OraRisk® COVID-19 RT-PCR Test from OralDNA® Labs
Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an Emergency Use Authorization for its OraRisk® COVID-19 RT-PCR test.
JANONE: Receives FDA Authorization for Transfer of Investigational New Drug (IND) Application for its Sodium Nitrite Tablets
IND transfer clears path for Phase 2b trials of potential Peripheral Artery Disease (PAD) treatment and opens the door to explore other vascular applications
BOSTON SCIENTIFIC: Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device
New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation
FDA: Proposes New Rule on Reporting Requirements
The U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act.
FDA: Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone
Goal is to Help Reduce Opioid Overdoses and Deaths
PREMIER INC.: Recommends FDA, DEA Reforms to Prevent Drug Shortages
Changes would provide greater flexibility to respond to surge demands and ensure that needed medications are readily available for patient care.
BECKMAN COULTER DIAGNOSTICS: Beckman Coulter's Automated Blood Banking Analyzer Receives 510(k) FDA Clearance
Beckman Coulter today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its PK7400 Automated Microplate System and the system's reagents have completed FDA approval.
FDA: Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death
CARISMA THERAPEUTICS: Announces FDA Clearance of IND Application for First-Ever Engineered Macrophage Immunotherapy
Plans to Initiate Phase 1 Clinical Trial This Year
STRATUS™ MEDICAL: Announces FDA 510k clearance for the Vesta™ RF Cannula to expand product portfolio and the first Vesta patient treatments in the United States
Stratus™ Medical, a company focused on advancing radiofrequency (RF) ablation treatment for chronic pain, announced today FDA clearance for the Vesta RF Cannula for use in radiofrequency (RF) heat lesion procedures for the relief of pain and first Vesta patient treatments in the United States.
FORESEE PHARMACEUTICALS: Announces Submission of NDA for FDA Approval of LMIS 50 mg
Foresee Pharmaceuticals Co., Ltd. (6576.TWO) ("Foresee"), announced today that it has submitted to the U.S. Food and Drug Administration a 505(b)(2) New Drug Application for Camcevi™ 42mg (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate.
GUIDED THERAPEUTICS: Submits Clinical Study Protocol to U.S. FDA for LuViva® Advanced Cervical Scan
Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced that it had submitted its protocol to FDA for a clinical study to support marketing of the LuViva® Advanced Cervical Scan in the United States.
REALTA LIFE SCIENCES: Announces U.S. FDA Clearance of First Investigational New Drug Application for RLS-0071
Phase 1 Trial for the Treatment of Patients with Acute Lung Injury Due to COVID 19 Anticipated to Begin in Third Quarter of 2020
SCPHARMACEUTICALS: Announces FDA Acceptance of FUROSCIX® New Drug Application Resubmission
FDA sets PDUFA date of December 30, 2020
CAN-FITE: Submits Investigational New Drug Application to U.S. FDA for COVID-19 Phase II Study
28-day study in hospitalized patients with moderate COVID-19 symptoms
NEURORX And RELIEF THERAPEUTICS: FDA grants Expanded Access Protocol to RLF-100 (Aviptadil) for Respiratory Failure in COVID-19: Currently in development by NeuroRx and Relief Therapeutics under Fast Track Designation
Expanded access is available to patients who are ineligible for enrollment in the FDA clinical trial of RLF-100, including pregnant women
FDA: Announces Voluntary Agreement with Manufacturers to Phase Out Certain Short-Chain PFAS Used in Food Packaging
The U.S. Food and Drug Administration is announcing that the manufacturers of certain per- and polyfluoroalkyl substances (PFAS) used for grease-proofing in paper and paperboard for food packaging (for example, as coatings on some fast-food wrappers, to-go boxes, and pizza boxes) have voluntarily agreed to phase-out their sales of these substances for use as food contact substances in the United States.
ABIOMED: FDA Issues Emergency Use Authorization for Impella Heart Pumps to Provide Unloading Therapy to COVID-19 Patients
The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients who are undergoing ECMO treatment and develop pulmonary edema or myocarditis.