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Drug Approval Equipment & Supplies
126 equipment items found
by:Curemark based inRye Brook, NEW YORK (USA)
Centers for Disease Control and Prevention estimate that 1 in 68 children in the United States have been diagnosed with Autism. There is currently no approved drug on the market that treats the core symptoms of Autism. At Curemark, we are working to change that. Curemark’s lead drug candidate, CM-AT, has received “Fast Track” ...
by:Starton Therapeutics based inParamus, NEW JERSEY (USA)
STAR-LLD is in development in two continuous delivery systems: subcutaneous and transdermal. STAR-LLD is being developed to establish the only IMiD (immunomodulatory drug) approved for CLL. CLL is the most common form of leukemia. Lenalidomide has been shown to be efficacious and well tolerated in CLL previous randomized controlled trials did not obtain an ...
Manufactured by:Creative Peptides based inNew York, NEW YORK (USA)
Dalbavancin (INN, trade name Dalvance) is a novel second-generation lipoglycopeptide antibiotic. It belongs to the same class as vancomycin.The Food and Drug Administration approved dalbavancin for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible ...
Manufactured by:SIGA Technologies, Inc. based inNew York, NEW YORK (USA)
Oral TPOXX® (tecovirimat) is the first drug approved by the U.S. Food and Drug Administration (FDA) that is specifically indicated for the treatment of smallpox disease in adults and pediatric patients weighing at least 13 kg. (Prescription Label) TPOXX® inhibits viral maturation of variola virus (the virus that causes smallpox) and other ...
Manufactured by:Quanterix Corporation based inBillerica, MASSACHUSETTS (USA)
For the first time, oncology and immuno-oncology researchers and others who rely on multiplexing capabilities have an easy-to-use platform to help optimize workflows, speed up their research and ultimately accelerate drug ...
Manufactured by:RareStone Group based inShanghai, CHINA
Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist, which increases the release of the brain chemical histamine to increase a patient's wakefulness and alertness. The drug was approved by the European Medicines Agency (EMA) in 2016 for the treatment of narcolepsy in adults with or with0out cataplexy and is marketed in major countries in ...
by:Curemark based inRye Brook, NEW YORK (USA)
Current prescription medications and psychosocial therapies focus on ameliorating primary symptoms. No currently approved drug treats the underlying cause of ADHD, and there is no known cure. Our pipeline includes a Phase III-ready drug product for ADHD. Preliminary studies with patients diagnosed with ADHD and taking prescribed ADHD medication ...
Manufactured by:Eleven P15 based inDenver, COLORADO (USA)
Idiopathic Pulmonary Fibrosis (IPF) is a chronic, fibrosing interstitial pneumonia of unknown cause, occurring primarily in older adults, and localized to the lung. IPF is a fatal disease with median survival at 3-5 years. Two drugs have been approved for treatment of IPF, but these drugs fail to reverse scarred lung tissue or to ...
Manufactured by:SIGA Technologies, Inc. based inNew York, NEW YORK (USA)
In October 2018, SIGA entered into a Cooperative Research and Development Agreement (CRADA) with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) with a focus on Good Laboratory Practice (GLP) studies of TPOXX® for PEP using a U.S. Food and Drug Administration (FDA)-approved non-human primate model of TPOXX® efficacy ...
Manufactured by:BRIM Biotechnology, Inc. based inTaipei City, TAIWAN
Neurotrophic Keratitis is a rare, degenerative disease characterised by corneal sensitivity reduction, spontaneous epithelium breakdown, and impairment of corneal healing. Currently, there is only one drug, Oxervate (Cenegermin), approved by the US FDA and EMA in 2018. Eye health is crucial to quality of life and BRIM is advancing new therapeutics to support ...
Manufactured by:Cellworks Research India Private Limited based inBangalore, INDIA
The Cellworks Platform biosimulates how a patient’s unique cancer will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. Therapy biosimulation is the ability to predict the phenotype response of a human cell to an external stimulus, such as a drug ligand or radiation. We utilize this ...
Manufactured by:Fate Therapeutics, Inc. based inSan Diego, CALIFORNIA (USA)
In multiple myeloma, malignant plasma cells accumulate in the bone marrow and produce abnormal antibodies called M proteins, which can cause kidney damage, bone destruction, and impaired immune function. While multiple approved drugs with novel mechanisms have improved disease management over the past decade, multiple myeloma is rarely curable and a significant ...
Manufactured by:Vivesto AB based inSolna, SWEDEN
Many intravenously delivered Active Pharmaceutical Ingredients (APIs) are insoluble or poorly soluble in water. This can be a major hurdle in pharmaceutical development and may cause promising drugs to fail during the development process and may limit the application of approved drugs because of poor solubility. According to some estimates, ...
Manufactured by:Vericel Corporation based inCambridge, MASSACHUSETTS (USA)
The U.S. Food and Drug Administration has approved MACI (autologous cultured chondrocytes on porcine collagen membrane) for the repair of symptomatic, full-thickness cartilage defects of the knee in adult patients. MACI is the first FDA-approved product that applies the process of tissue engineering to grow cells on scaffolds using healthy ...
Manufactured by:Premier Biotech, Inc. based inMinneapolis, MINNESOTA (USA)
Premier Biotech’s CLIA-Waived (Clinical Laboratory Improvement Amendments) multi-drug integrated cup and dip products offer the ability to test for 5-14 drugs. CLIA-Waived test products are cleared by the FDA for over-the-counter (OTC) use, suited for workplace and clinical drug testing programs and approved for waiver ...
Manufactured by:Cerevast Medical, Inc. based inBothell, WASHINGTON (USA)
The formation or deposition of these clots in the arterial vessels of the brain is one of the primary causes of ischemic stroke. Intravenous thrombolytic therapy (tPA/alteplase, the only approved drug for the treatment of ischemic stroke) works by converting plasminogen in the blood stream to plasmin, the active enzyme that dissolves ...
Manufactured by:AllCells based inAlameda, CALIFORNIA (USA)
AllCells’ GMP Mobilized leukopaks are apheresis products collected from healthy donors treated with FDA-approved drugs to stimulate mobilization of CD34+ hematopoietic stem and progenitor cells from the bone marrow to the peripheral blood. This procedure results in large-scale yields of CD34+ cells. Peripheral blood is collected from IRB-consented donors ...
by:ImageProVision Technology Pvt. Ltd. based inPune, INDIA
This system improves the accuracy and efficiency of microscopic particle characterization, making it particularly useful in pharmaceutical applications such as new drug development, FDA approval processes, and ANDA filings. The software is user-friendly, flexible, and interactive, simplifying complex analysis tasks for professionals in the ...
by:Sibylla Biotech S.p.A. based inVerona, ITALY
In Silico: Identifying small molecules able to revolutionize drug discovery. The PPI-FIT technology allows the exploration of unique pharmacological targets represented by protein folding intermediates. This places Sibylla Biotech in the exclusive position of identifying hit/lead compounds with a mechanism of action never explored so far. ...
Manufactured by:AllCells based inAlameda, CALIFORNIA (USA)
Mobilized Leukopaks are apheresis products collected from healthy donors treated with FDA-approved drugs to stimulate the migration of CD34+ hematopoietic stem and progenitor cells (HSPCs) from the bone marrow niche into the circulation. Mobilized peripheral blood, enriched in single-donor CD34+ HSPCs is collected through leukapheresis using the Spectra ...