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
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SCPHARMACEUTICALS: Announces FDA Acceptance of FUROSCIX® New Drug Application Resubmission
FDA sets PDUFA date of December 30, 2020
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
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.
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.
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.
CARISMA THERAPEUTICS: Announces FDA Clearance of IND Application for First-Ever Engineered Macrophage Immunotherapy
Plans to Initiate Phase 1 Clinical Trial This Year
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
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.
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.
FDA: Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone
Goal is to Help Reduce Opioid Overdoses and Deaths
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.
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
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
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.
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
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
QUEST DIAGNOSTICS: FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use
First FDA authorization of laboratory technique for use in COVID-19 diagnostic testing
CLINICAL COMPUTER SYSTEMS, INC.: Announces FDA 510(k) Clearance for OBIX BeCA® Fetal Monitor
Clinical Computer Systems, Inc. (CCSI), a leading provider of perinatal software, is looking forward to a successful launch of the new OBIX BeCA fetal monitor which recently obtained FDA 510(k) clearance.
ABIOMED: FDA Approves Data Streaming from the Impella Console, Setting the Stage for Artificial Intelligence Algorithms to Further Improve Patient Outcomes
The United States Food and Drug Administration (FDA) has approved one-way digital data streaming during patient support from Abiomed's (NASDAQ: ABMD) Automated Impella Controller (AIC), the external console used with Impella heart pumps.