Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company at the forefront of stem cell-based delivery of oncolytic viruses, announced that the Investigational New Drug (IND) application submitted by its partner, Personalized Stem Cells, Inc. (PSC), has received FDA approval for the treatment of COVID-19 and pneumonia patients using stem cell therapy.
ReViral Ltd., a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing antiviral therapeutics that target respiratory syncytial virus (RSV), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sisunatovir for the treatment of patients with serious RSV infection.
The purpose of the Fast Track process is to get important potential new drugs to patients earlier
The U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies present in the individual’s blood.
The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older.
The EPA-approved protocol can be used to evaluate the effectiveness of treatments in reducing microbial contamination in agricultural water
U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC.
The U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.
Checkmate Pharmaceuticals, Inc. (Checkmate), a clinical-stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its product candidate, CMP-001
NIT’s second trial to evaluate NT-I7’s potential as a COVID-19 therapeutic
This latest clearance makes Zebra Medical the first AI startup with six FDA clearances across three different modalities under its belt. In initial testing Zebra-Med conducted, a number of cases which were originally missed were alerted by Zebra Medical’s ‘HealthMammo’ algorithm and the patients were recalled and confirmed
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced that its partner, Austrianova, has submitted a Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA).
Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, announced that its prophylactic breast cancer vaccine is making progress towards clinical trials.
Designations Highlight the Urgent Need for Treatments for These Rare Diseases
Vita Therapeutics, Inc. announced that it received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne's Muscular Dystrophy (DMD).
87 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus
Authorization is also second to allow testing of pooled samples
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The U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.
World's first single-use two channel ECG and heart rate biosensor provides 72-hour patient monitoring with remote data access in ambulatory, hospital and home settings
Next-generation technology enhances ease-of-use for physicians and streamlines manufacturability