ExeGi Pharma LLC, a company focused on developing live biotherapeutic ("LBP") drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis.
Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL® Cell Therapy) to Treat Organ Vascular Niche Injuries for the Prevention of Severe Toxicities in Lymphoma Patients undergoing Curative High-Dose Therapy with Autologous Stem Cell Transplantation
The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for Eli Lilly and Company's (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg.
AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on rare, childhood onset neurogenetic disorders with limited or no treatment options, announced that the U.S. Food and Drug Administration (FDA) has granted a Rare Pediatric Disease (RPD) designation to AMO-Pharma for AMO-02, the company's investigational therapy in development for the treatment of congenital myotonic dystrophy.
The U.S. Food and Drug Administration authorized the first serology test that detects neutralizing antibodies from recent or prior SARS-CoV-2 infection, which are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease SARS-CoV-2 viral infection of cells.
Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and its gastroenterology business, Salix Pharmaceuticals ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to rifaximin for the treatment of sickle cell disease.
reVision Therapeutics, Inc., a privately-held, early stage biopharmaceutical company focused on the development and commercialization of innovative therapies for ocular and rare diseases, announced that the US Food and Drug Administration has granted the Company's request to designate REV-0100 as an Orphan-Drug and a Rare Pediatric Disease Drug for the treatment of Stargardt disease.
Company Confirms COVID-19 Antibody Home Test and Two Severity Triage Tests can be Submitted to U.S. FDA Under Emergency Use Authorization
The MOU will maximize inspection and detection capabilities in order to prevent this illegal activity.
In Phase 2b development for the treatment of life-threatening fungal infections
The U.S. Food and Drug Administration (FDA) reissued the Emergency Use Authorization (EUA) for certain filtering face-piece respirators (FFRs) that are manufactured in China and are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH).
The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs).
The U.S. Food and Drug Administration’s mission to protect and promote public health by ensuring the safety of the nation’s food supply, as well as the safety and efficacy of medical products, has always relied on a rigorous analysis of the scientific data available and a strong commitment to safety.
Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA
Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ION373 for the treatment of people with Alexander disease, a severe, progressive and debilitating rare neurodegenerative disease that can result in death.
The International Academy of Oral Medicine and Toxicology (IAOMT) is commending the Food and Drug Administration (FDA) for its statement yesterday that warns high-risk groups about the potential for adverse health outcomes from dental amalgam mercury fillings.
