FDA plans 19 public meetings in October
Nineteen public meetings, conferences or workshops sponsored by the U.S. Food and Drug Administration have been scheduled for October, the FDA reported.
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PUMA BIOTECHNOLOGY: FDA Approves Labeling Supplement for Puma Biotechnology’s NERLYNX® (neratinib) for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer
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.
BIOFOURMIS: Biofourmis' Biovitals™ Analytics Engine Receives FDA Clearance for Ambulatory Physiologic Monitoring
Milestone approval establishes AI-powered solution as the foundation for future disease-specific predictive management tools from Biofourmis
PACIFIC KETAMINE INSTITUTE: Introduces SPRAVATO™ Treatment for Depression and Mental Disorders
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.
JANSSEN: Announces U.S. FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer
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
AMERICA'S BLOOD CENTERS: Urges FDA to Continue to Evaluate Impact of New Final Guidance on Platelet Availability
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.
U.S. FDA: Approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic
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.
JANSSEN: Submits Application to U.S. FDA Seeking Approval of STELARA®(ustekinumab) for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
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).
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AETHLON MEDICAL: Announces FDA Approval Of IDE For Oncology Indications
Will allow initiation of Early Feasibility Study in Head and Neck Cancer
NOVARTIS: Receives FDA approval for BEOVU®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept
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)
DEXCOM: Announces FDA Clearance of New Dexcom G6 Pro CGM
First and only single-use, professional CGM system with blinded or unblinded mode
PQ BYPASS: Announces Unconditional IDE Approval From U.S. FDA to Start TORUS SFA Stent Graft Pivotal Study (TORUS-2)
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years.
Washington Policy Center analyst says black-market THC products to blame for vaping deaths, illnesses
As Congress criticizes the Food and Drug Administration (FDA) for its 2017 delay of reviewing e-cigarettes and vaping products, and blames the agency for the current vaping-illness outbreak across the U.S., Washington Policy Center Health Care Policy Analyst Roger Stark, M.D., is stressing to the nation that the FDA should not be held responsible for the recent surge in health emergencies.
OCTAPHARMA USA: FDA Approves Octapharma’s WILATE® for Hemophilia A in Adult and Adolescent Patients
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.
FDA grants marketing approval for Australian product that treats rare skin disease
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).
Vitosa stevia sweetener receives 'Letter of No Objection' from the FDA
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.
FIRSTKIND LTD: FDA Clears GEKO DEVICE for Use in Non-surgical Patients at Risk for Deep Vein Thrombosis Based on Study Demonstrating a Zero Percent DVT Rate in Patients After a Stroke
Sky Medical Technology furthers presence in 3.5bn1 dollar US market for VTE prevention
U.S. FDA: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens
The U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid).
EICOSIS: Announces FDA Acceptance of IND Application for EC5026, the First Soluble Epoxide Hydrolase Inhibitor to Treat Pain
EicOsis LLC, a pharmaceutical startup developing a new class of oral non-narcotic analgesics, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to initiate Phase 1 clinical trials for their drug candidate, EC5026, for the treatment of pain.
BOEHRINGER INGELHEIM: FDA Grants Ofev® Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
The designation was supported by results from the Phase III INBUILD® study that met its primary endpoint and was recently published in the New England Journal of Medicine