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Applied BioCode announced that it has received U.S. Food and Drug Administration 510(k) clearance for the use of the Roche MagNA Pure 96* Extraction System with the high throughput BioCode® MDx-3000 and Gastrointestinal Pathogen Panel (GPP).
Bolder BioTechnology, Inc. announced that its long-acting IL-11 analog, BBT-059, has received Orphan Drug designation from the Food and Drug Administration for treatment of Acute Radiation Syndrome (ARS).
In-silico bioequivalence approach using Simcyp’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model successfully replaced in-vivo, clinical studies in FDA AND
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Rituxan in combination with glucocorticoids is the only FDA-approved therapy for adults with these two rare forms of vasculitis
The IB-Stim would be used in combination with other IBS therapies.
Today, a group of ALS patients will come together to protest at the Food and Drug Administration building in Maryland to say they have not seen a response in research from the $115 million raised globally from the ice bucket challenge.
Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Aimed at reducing medication errors and related healthcare costs, Ivenix prepares to bring its infusion system to the $4.7 billion North American infusion market
KEYTRUDA Now Approved for First-Line Treatment of Patients with Metastatic or with Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma as Monotherapy for Patients Whose Tumors Express PD-L1 (CPS ≥1) or in Combination with Platinum and Fluorouracil (FU) Regardless of PD-L1 Expression
Few cancer drugs that received accelerated Food and Drug Administration approval lived up to their billing, according to a JAMA study.
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The U.S. Food and Drug Administration approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes.
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Torque, a clinical-stage immuno-oncology company developing Deep-Primed™ T Cell Therapeutics to direct immune power deep within the tumor microenvironment, announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Torque's first Deep-Primed™ T cell immunotherapy program, TRQ-1501 (Deep IL-15 Primed T cells).
WASHINGTON -- A low percentage of cancer drugs that received accelerated Food and Drug Administration approval had positive results in the long run, according to a recent study by the Journal of the American Medical Association.
ReNetX Bio, Inc., a leading biotechnology company committed to reversing disease and damage for patients suffering from central nervous system disorders, has announced that the U.S. Food and Drug Administration (FDA) has allowed the Company's Investigational New Drug (IND) application for its lead drug candidate, fusion protein AXER-204.
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Camurus (NASDAQ STO: CAMX), a commercial stage biopharmaceutical company specializing in long-acting medicines for severe and chronic disorders, announced today the acceptance by the US Food and Drug Administration (FDA) of an Investigational New Drug (IND) application to initiate a Phase 3 study with CAM2029 once-monthly octreotide subcutaneous depot for treatment of acromegaly.
Food producers carried out 46 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
The FDA is working toward better regulation of cannabis-based products, consulting services firm Kline said after a public hearing with the U.S. regulatory body.
Jane Orient, executive director of the Association of American Physicians and Surgeons and president of Doctors for Disaster Preparedness, believes it’s the latest example of chemophobia.
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