New Drug Application (NDA) is supported by data from pivotal Phase 3 studies of nearly 800 patients
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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.
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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).
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
PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify ESCC patients
US Medical Innovations, LLC (USMI), a Biomedical and Life Science subsidiary of US Patent Innovations, LLC and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS)™, LLC announced that the U.S. Food and Drug Administration (FDA) has approved the first clinical trial in the U.S. to evaluate Cold Atmospheric Plasma (CAP) Technology for the treatment of cancer.
Nubeqa was approved under the FDA's Priority Review designation; approval granted three months ahead of target FDA action date
Binge eating disorder (BED) is estimated to affect 4.1 million Americans and may occur at a rate that is three times higher than anorexia and bulimia combined1
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MiRus™ Receives FDA 510(k) Clearance for CYGNUS™ Anterior Cervical Plate
The national food safety law firm of Ron Simon & Associates filed the first lawsuit against Siga Logistics de RL de CV, the Mexican producer and importer of fresh basil linked by health officials to a nationwide cyclospora outbreak.
The Natural Medicines FDA Advisory tool identifies commercial products containing ingredients flagged by the FDA, and provides resources on safety and use to help mitigate risks to patients.
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 U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL.
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).
Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
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.
Apic Bio, Inc., an innovative gene therapy company developing novel treatment options for patients with rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to APB-102, a gene therapy soon to be in clinical development for the treatment of genetic SOD1 amyotrophic lateral sclerosis (ALS).