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DEXTENZA Now Approved for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery
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Allergan plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental biologics application (sBLA) for BOTOX® for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. BOTOX® was granted a six-month Priority Review by the FDA, which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care.
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.
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.
Food producers carried out 46 food or dietary supplement product recalls over the past month, according to the U.S. Food and Drug Administration.
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.
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.
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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).
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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.
Few cancer drugs that received accelerated Food and Drug Administration approval lived up to their billing, according to a JAMA study.
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
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
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.
The IB-Stim would be used in combination with other IBS therapies.
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Rituxan in combination with glucocorticoids is the only FDA-approved therapy for adults with these two rare forms of vasculitis
In-silico bioequivalence approach using Simcyp’s Multi-Phase Multi-Layer Mechanistic Dermal Absorption model successfully replaced in-vivo, clinical studies in FDA AND
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).
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).
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