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INNOVA THERAPEUTICS: Receives Rare Pediatric Disease Designation from the Food and Drug Administration (FDA) for IVT-8086 for the Treatment of Osteosarcoma

By Press release submission | Sep 25, 2020

Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate treatment options, today announced that the FDA has granted Rare Pediatric Disease (RPD) Designation for IVT-8086 for the treatment of Osteosarcoma (OS). IVT-8086 is a humanized monoclonal antibody (mAb) with high affinity to a novel anticancer target, secreted frizzled-related protein 2

SPIROVANT: FDA Grants Spirovant Sciences Orphan Drug and Rare Pediatric Disease Designations for SPIRO-2101 for Treatment of Cystic Fibrosis

FDA Approval

By Press release submission | Sep 26, 2020

Spirovant Sciences, a gene therapy company developing treatments and cures for genetic lung diseases including cystic fibrosis, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease Designations to its lead product candidate, SPIRO-2101, for the treatment of cystic fibrosis.

IAOMT: FDA Issues Mercury Amalgam Filling Warning, Group Calls For Even More Protection

Regulation

By Press release submission | Sep 26, 2020

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.

FDA: Takes Actions to Help Lower U.S. Prescription Drug Prices

Reform

By Press release submission | Sep 27, 2020

Final Rule, Guidance Fulfill Plan for Safe Importation of Certain Drugs Originally Intended for Foreign Markets

FDA: Approves First Drug to Treat Group of Rare Blood Disorders in Nearly 14 Years

FDA Approval

By Press release submission | Oct 5, 2020

Approval is for hypereosinophilic syndrome, which occurs when there is a high number of a type of white blood cells

FDA: Approves Drug Combination for Treating Mesothelioma

FDA Approval

By Press release submission | Oct 5, 2020

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

FDA Approval

By Press release submission | Oct 7, 2020

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

Regulation

By Press release submission | Oct 7, 2020

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

Patients

By Press release submission | Oct 7, 2020

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

Patients

By Press release submission | Oct 9, 2020

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

Patients

By Press release submission | Oct 9, 2020

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

FDA Approval

By Press release submission | Oct 10, 2020

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

FDA Approval

By Press release submission | Oct 10, 2020

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

Regulation

By Press release submission | Oct 10, 2020

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

Regulation

By Press release submission | Oct 12, 2020

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

By Press release submission | Oct 12, 2020

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.

FDA: Warns Dietary Supplement Companies Illegally Selling Products Containing Cesium Chloride

Regulation

By Press release submission | Oct 13, 2020

U.S.

DIRECT BIOLOGICS: Granted Expanded Access by FDA for ExoFlo™ in the Treatment of COVID-19

FDA Approval

By Press release submission | Oct 13, 2020

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

FDA Approval

By Press release submission | Oct 13, 2020

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

FDA Approval

By Press release submission | Oct 16, 2020

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.

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