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.
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.
Exclusive distribution agreement with Daiichi Sankyo, Inc. expands rare disease and complex therapeutic specialty pharmacy needs
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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
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.
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
Nubeqa was approved under the FDA's Priority Review designation; approval granted three months ahead of target FDA action date
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MiRus™ Receives FDA 510(k) Clearance for CYGNUS™ Anterior Cervical Plate
The U.S. Food and Drug Administration approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection.
The FDA's partial clinical hold on a phase 3 study of Venetoclax was lifted thanks to an agreement to revisions to the CANOVA study protocol.
The Food and Drug Administration gave Micro Medical approval for an Investigational Device Exemption (IDE) to start a clinical trial to investigate the safety of the MicroStent.
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Company Aligns with FDA on Planned Confirmatory Study Design for Tazemetostat in Epithelioid Sarcoma
Pfizer Inc. (NYSE:PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Pregabalin capsules on July 19th. The patent expiration for the brand Lyrica© marketed by Pfizer, occurred on that day which cleared the way for the company to begin immediate shipping of the product.
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On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.
