Approval marks the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs and signals FDA’s continued focus on facilitating development of new treatments to fight antimicrobial resistant infections
binx io enables first-ever "test-and-treat" paradigm with sample to answer in 30 minutes for the two most tested-for sexually transmitted infections (STIs)
The multi-center PROACTIVE-HF trial of the Cordella Pulmonary Artery (PA) Pressure Sensor System (Cordella Sensor) has been approved by the Food and Drug Administration (FDA). The point of the trial is to expedite pre-market approval (PMA) of the Cordella Sensor and provide evidence to the Centers for Medicare & Medicaid Services (CMS).
Diagnosing Lyme disease is notoriously difficult, so the announcement from the Food and Drug Administration (FDA) that four cleared tests with new indications are now cleared for marketing brings hope to the many who suffer from the disease.
Company expects to initiate Phase 1 / 2 study 'Unite-CNM' in 2H2019
Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-123 (tazarotene 0.045%) Lotion with a PDUFA action date of Dec. 22, 2019.
Vesselon (www.vesselon.com), an oncology therapeutics company, announced the acquisition of an FDA-approved drug Imagent®. Vesselon will use Imagent to create novel therapeutic complexes in four classes of cancer drugs: cytokines, oncolytic viruses, monoclonal antibodies, and nucleic acid constructs.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Exclusive distribution agreement with Daiichi Sankyo, Inc. expands rare disease and complex therapeutic specialty pharmacy needs
FDA grants priority review and sets PDUFA date for February 14, 2020
Stoke Therapeutics, Inc., (Nasdaq: STOK), a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein expression, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead product candidate, STK-001, an investigational new treatment for Dravet syndrome.
As a public health agency, we believe that it is critical to facilitate the development of innovative safe and effective medical products, like the cellular and gene therapy products that have shown enormous potential to treat previously untreatable diseases.
Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for FMX103 for the treatment of moderate-to-severe papulopustular rosacea in patients 18 years of age and older.
New Drug Application (NDA) is supported by data from pivotal Phase 3 studies of nearly 800 patients
President of the Board for The Consumer Advocates for Smoke-free Alternatives Association (CASAA) Bruce Nye compares the Food and Drug Administration’s (FDA) recent $60 million dollar anti-vaping television campaign to “propaganda” and “sloganeering.”
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As the U.S. Food and Drug Administration (FDA) is being flooded with requests to allow CBD in food and supplements, marijuana advocacy groups are eager for federal regulators to monitor the marketplace to help establish some semblance of order.
The leading vertically integrated multi-state cannabis operator in the U.S. issued a statement last week about a letter it received from the Food and Drug Administration (FDA) addressing the company's CBD product marketing.
An agreement between pharmaceutical company Scynexis and the U.S. Food and Drug Administration (FDA) was reached under a special protocol assessment (SPA) on the details of the CANDLE (Conditions Affecting Neurocognitive Development and Learning in Early childhood) study for Oral Ibrexafungerp.
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TURALIO is the first and only approved therapy for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery
