HB Natural Ingredients has received a "Letter of No Objection" for Vitosa stevia sweeteners from the U.S. Food and Drug Administration (FDA), confirming that the agency has "no questions" on the self-affirmed GRAS (generally recognized as safe) status of Vitosa for use as a sweetener in food and beverage products.
The U.S. Food and Drug Administration (FDA) recently granted marketing approval to use Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
Octapharma USA announced the U.S. Food and Drug Administration (FDA) has approved WILATE® for treatment of adults and adolescents with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes and on demand treatment and control of bleeding episodes.
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years.
First and only single-use, professional CGM system with blinded or unblinded mode
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved BEOVU® (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD)
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Will allow initiation of Early Feasibility Study in Head and Neck Cancer
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric (ages 6-11) patients with moderate to severe plaque psoriasis (PsO).
The U.S. Food and Drug Administration approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
America's Blood Centers (ABC) encourages the Food and Drug Administration (FDA) to continue to assess the impact of the Final Guidance issued on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Guidance for Industry.
Niraparib, an orally-administered PARP inhibitor, is currently being investigated for the treatment of patients with metastatic castration-resistant prostate cancer and BRCA1/2 DNA repair gene defects
Pacific Ketamine Institute (PKI), a pioneer in treating depression, PTSD, and chronic pain using Ketamine-based treatments, announced today that it has officially started offering patients the new FDA-approved esketamine nasal spray, SPRAVATO™, at its flagship Beverly Hills treatment center.
Milestone approval establishes AI-powered solution as the foundation for future disease-specific predictive management tools from Biofourmis
Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.
Novartis recently reported results from the MONALEESA-3 trial, the largest to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women (N=726), which showed that CDK4/6 inhibitor Kisqali (ribociclib) demonstrated statistically significant improvement in overall survival (OS).
Eli Lilly and Company recently announced that results of the LIBRETTO-001 clinical trial intended to support the registration of oral selpercatinib monotherapy, also known as LOXO-292, were presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain.
Epica International, Inc. (Epica), received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SeeFactorCT3™ Imaging Platform. SeeFactorCT3™ consists of 3 integrated imaging systems: CT, Fluoroscopy and Digital Radiography; a detachable patient table/chair, and sterile drape for interventional procedures. FDA clearance allows Epica to market these products in the United States.
Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a 6-month review by the FDA.
The National Kidney Foundation Statement about INVOKANA® (Canagliflozin)
INVOKANA® is the only diabetes medicine indicated to slow the progression of diabetic nephropathy (also known as DKD) and reduce the risk of hospitalization for heart failure in patients with T2D and DKD