FDA: Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years
Approval is for hypereosinophilic syndrome, which occurs when there is a high number of a type of white blood cells
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FDA: Approves Drug Combination for Treating Mesothelioma
First approval in 16 years for mesothelioma, a type of cancer caused by inhaling asbestos fibers
CSL BEHRING: U.S. Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
HAEGARDA is the first and only subcutaneous prophylactic HAE treatment approved for children 6 years of age and older
IONIS: Treatment for Alexander disease receives orphan drug designation from 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.
AEGLE THERAPEUTICS CORPORATION: FDA Grants Fast Track Status to Aegle Therapeutics' AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa
Aegle Therapeutics Corporation today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AGLE-102™ for the treatment of patients with dystrophic epidermolysis bullosa ("DEB"), a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle ("EV") therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue. AGLE-102 will be evaluated in DEB patients in a phase 1/2a trial initiating in 2021.
CARSGEN THERAPEUTICS: Granted Orphan Drug Designation by the US FDA for CT041 CLDN18.2 CAR-T Cells for the Treatment of Gastric and Gastroesophageal Junction Cancers
CARsgen Therapeutics Co., Ltd., a clinical-stage biopharmaceutical company, announced that the United States (US) Food and Drug Administration (FDA) has granted orphan drug designation to one of CARsgen's first-in-class drug candidates, CT041, for the treatment of gastric and gastroesophageal junction adenocarcinoma.
AEGLE THERAPEUTICS: Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for AGLE-102 for Patients with Dystrophic Epidermolysis Bullosa
Aegle Therapeutics Corporation, a first-in-class biotechnology company committed to delivering cell-free therapy to patients affected by severe dermatological conditions, announced that the FDA has granted Rare Pediatric Disease (RPD) Designation to AGLE-102™ for the treatment of dystrophic epidermolysis bullosa (DEB), a skin blistering disorder.
BIOSENSE WEBSTER: Receives FDA Approval for THERMOCOOL SMARTTOUCH® SF Ablation Catheter for the Treatment of Persistent Atrial Fibrillation
The CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in persistent atrial fibrillation patients*
CLYRA MEDICAL TECHNOLOGIES: Clyraguard, A Hospital-Grade, FDA-Registered Disinfectant For Face Masks And Coverings, Is Now Available To Consumers
Tested at Galveston National Laboratory, Clyraguard has shown complete inactivation of SARS-CoV-2 (COVID-19), providing an additional safeguard against airborne viruses
BECKMAN COULTER: SARS-CoV-2 IgM Antibody Test Receives FDA Emergency Use Authorization
Beckman Coulter's Access SARS-CoV-2 IgM antibody assay receives Emergency Use Authorization from the U.S. FDA
FDA: Reaffirms Commitment to Safety, Security of its Public Health Laboratories
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.
FDA: Awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
The U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years.
DIRECT BIOLOGICS: Granted Expanded Access by FDA for ExoFlo™ in the Treatment of COVID-19
Direct Biologics, LLC, announced today that the FDA has granted expanded access for ExoFlo in the treatment of patients with COVID-19 associated acute respiratory distress syndrome (ARDS).
CEFALY TECHNOLOGY: Now Over-the-Counter: FDA Clears CEFALY® DUAL Migraine Treatment for Use Without a Prescription
The first external Trigeminal nerve stimulator for the treatment of migraine headaches is now also the first available without a prescription
FDA: Approves First Treatment for Ebola Virus
The U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.
FDA: Warns that Using a Type of Pain and Fever Medication in Second Half of Pregnancy Could Lead to Complications
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).
FDA: Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China
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).
BIOHAVEN: U.S. FDA Accepts Biohaven's Supplemental New Drug Application (sNDA) Of NURTEC™ ODT For The Preventive Treatment Of Migraine
Acceptance marks critical milestone in Biohaven's efforts to develop NURTEC ODT as a unique dual therapy for both the preventive and acute treatment of migraine
TEVOGEN BIO: Announces IND Submitted to FDA for Clinical Trials of T Cell Treatment for COVID-19
Tevogen Bio, today announced that its Investigational New Drug (IND) application to develop a COVID-19 treatment using proprietary antigen specific T cell technology has been submitted to the US Food and Drug Administration (FDA).