FDA approves Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis in patients 12 years and older; Agency grants pediatric exclusivity extending U.S. market exclusivity
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Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, was selected by Bayer HealthCare as a specialty pharmacy provider for NUBEQA® (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC).
The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
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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
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.
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.
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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.
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.”
New Drug Application (NDA) is supported by data from pivotal Phase 3 studies of nearly 800 patients
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.
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.
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.
FDA grants priority review and sets PDUFA date for February 14, 2020
Exclusive distribution agreement with Daiichi Sankyo, Inc. expands rare disease and complex therapeutic specialty pharmacy needs
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.
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.
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.
Company expects to initiate Phase 1 / 2 study 'Unite-CNM' in 2H2019
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.
