FDA approves trial of MicroStent leg amputation device
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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FDA lifts hold on phase 3 study of Venetoclax
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.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for severe hypoglycemia that can be administered without an injection
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.
TRC HEALTHCARE: New Tool Helps Healthcare Providers Leverage FDA's Dietary Supplement Ingredient Advisory List To Inform Care Decisions And Advise Patients
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.
RON SIMON & ASSOCIATES: First Mexican Basil Cyclospora Lawsuit Filed by National Food Safety Law Firm of Ron Simon & Associates as FDA Identifies 132 Victims in Mexican Basil Cyclospora Outbreak
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.
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MIRUS: Receives FDA Clearance for Lowest Profile Anterior Cervical Plate System
MiRus™ Receives FDA 510(k) Clearance for CYGNUS™ Anterior Cervical Plate
SUNOVION: Announces Acceptance by the U.S. FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder
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
BAYER: FDA approves Bayer's Nubeqa® (darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer
Nubeqa was approved under the FDA's Priority Review designation; approval granted three months ahead of target FDA action date
US MEDICAL INNOVATIONS: USMI and JCRI-ABTS Receive FDA Approval to Conduct the First U.S. Clinical Trial Using Cold Atmospheric Plasma for the Treatment of Cancer
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.
AGILENT TECHNOLOGIES INC.: Agilent Companion Diagnostic Gains Expanded FDA Approval in Esophageal Squamous Cell Carcinoma (ESCC)
PD-L1 IHC 22C3 pharmDx can now be used as an aid to identify ESCC patients
LEO PHARMA: Announces U.S. Food and Drug Administration (FDA) Expanded Regulatory Approvals for Enstilar® Foam and Taclonex® Topical Suspension in Treatment of Plaque Psoriasis
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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MCKESSON: NUBEQA® (darolutamide), FDA Approved for Treatment of High-Risk Non-Metastatic Prostate Cancer, Available at Biologics by McKesson
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).
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first therapy for rare joint tumor
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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DAIICHI SANKYO: FDA Approves Daiichi Sankyo's TURALIO™ (pexidartinib) for the Treatment of Select Patients with TGCT, a Rare and Debilitating Tumor
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
Phase 3 CANDLE study slated for Scynexis treatment of VVC
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.
Curaleaf receives FDA letter about CBD product marketing
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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Cannabis advocates urge FDA to ramp up CBD regulation
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.
CASAA condemns FDA's new anti-vaping ad campaign
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.”
ABBVIE: Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women
New Drug Application (NDA) is supported by data from pivotal Phase 3 studies of nearly 800 patients
FOAMIX PHARMACEUTICALS: Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
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.