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Drug Designation Equipment Supplied In USA
61 equipment items found
by:Vybion based inMonterey, CALIFORNIA (USA)
INT41 has received Orphan Drug Designation from the FDA for Huntington’s disease. IND enabling studies for INT41 Gene Therapy for Huntington’s disease are in place following a preIND meeting with the FDA in in February 2022 in response to the briefing book prepared by our consultants at Latham BioPharm, a world class consulting group based in ...
Manufactured by:Tonix Pharmaceuticals Holding Corp. based inChatham, NEW JERSEY (USA)
TNX-2900, Tonix’s proprietary potentiated intranasal oxytocin is in the pre-Investigational New Drug (IND) stage as a candidate for the treatment of Prader-Willi syndrome (PWS) and non-organic failure to thrive disease. TNX-2900 has been granted Orphan Drug Designation (ODD) in the US by the FDA for the treatment of ...
Manufactured by:Notitia Biotechnologies based inMonmouth Junction, NEW JERSEY (USA)
NM108 is an investigational botanical drug that is designed to treat diseases by promoting the growth of either the existing or replenished Foundation Guild™ bacteria in a patient's gut microbiome. NM108 is currently in phase 2 trial as well as available for Expanded Access (compassionate ...
Manufactured by:Alfa Chemistry based inNew York, NEW YORK (USA)
Introducing fluorine atom(s) into bioactive organic compounds has become a leading strategy for drug design and lead optimization. In drug synthesis strategy, fluorine is frequently employed to modify biologically relevant properties such as metabolic stability, basicity, lipophilicity and bioavailability. Additionally, the binding affinity of ...
Manufactured by:Notitia Biotechnologies based inMonmouth Junction, NEW JERSEY (USA)
BM306 is an investigational live biotherapeutic product that contains the Foundation Guild™ bacteria in a defined consortium. This investigational drug is designed to treat diseases by replenishing the missing or extinct Foundation Guild™ bacteria in a patient's gut ...
Manufactured by:Cellphire Therapeutics, Inc. based inRockville, MARYLAND (USA)
The product is currently in a Phase 2 clinical trial in bleeding thrombocytopenic patients. Thrombosomes has also been given orphan drug designation for the treatment of Acute Radiation Sickness by the U.S. Food and Drug ...
Manufactured by:Seres Therapeutics, Inc. based inCambridge, MASSACHUSETTS (USA)
SER-287 is a consortium of multiple bacterial spores manufactured by fractionating and purifying targeted bacteria from stool of healthy human donors. SER-287 has been granted Fast Track designation and Orphan Drug designation by the FDA. A completed SER-287 Phase 1b clinical study demonstrated a statistically significant difference in the ...
Manufactured by:Kala Pharmaceuticals, Inc. based inArlington, MASSACHUSETTS (USA)
AMPPLIFY Drug Delivery Technology is designed to enhance penetration through the mucus barrier and deliver increased concentration of drug to the target ocular tissue. AMPPLIFY Drug Delivery Technology has been shown to improve delivery of loteprednol etabonate compared to traditional suspension eyedrops without ...
Manufactured by:Advin Biotech, Inc. based in, CALIFORNIA (USA)
Our new iSplit Cup and POCiT cup are examples of Advin’s focus on innovative engineering that result in improvements in the drug testing field. These designs remove steps in the lab and/or reduce shipping costs and storage footprint without the need for handling sharps or extra components. Both cups have patents pending and are exclusively available from ...
Manufactured by:Protara Therapeutics, Inc. based inNew York, NEW YORK (USA)
Because PN patients cannot sufficiently absorb adequate levels of choline and no available PN formulations contain sufficient amounts of choline to correct this deficiency, PN patients often experience a prolonged progression to hepatic failure and death, with the only known intervention being a dual small bowel / liver transplant. If approved, IV choline chloride would be the first approved ...
Manufactured by:Shamrock Labels based inBellwood, ILLINOIS (USA)
The Shamrock Model SA-1 Anesthesia Drug Labels for Syringe Identification are designed for precise and clear labeling in critical medical environments. Each roll measures 1/2" x 500", providing ample length for extensive use. The labels come in a roll format with a removable adhesive, ensuring they can be easily applied and repositioned without leaving residue. ...
Manufactured by:YourChoice Therapeutics based inSan Francisco, CALIFORNIA (USA)
Blocks Cell Division and Blocks Sperm Release enabled by a proprietary ...
Manufactured by:Cabaletta Bio, Inc. based inPhiladelphia, PENNSYLVANIA (USA)
Our lead product candidate, DSG3-CAART, is being developed to treat mucosal pemphigus vulgaris (mPV), a blistering skin disease that affects mucous membranes. mPV is caused by autoantibodies that attack the cell adhesion protein desmoglein 3, or DSG3. DSG3-CAART is designed to selectively target and kill the B cells that produce DSG3 antibodies while preserving the healthy B ...
Manufactured by:Creative Biogene based inShirley, NEW YORK (USA)
The mammalian ERCC1 (Excision Repair Cross Complementing) polypeptide is required for nucleotide excision repair (NER) of damaged DNA and is homologous to Saccharomyces cerevisiae RAD10, which functions in repair and mitotic intrachromosomal recombination. NER mechanism involves dual incisions on both sides of the damage catalyzed by two nucleases. In mammalian cells XPG cleaves 3" of the DNA ...
Manufactured by:Berkshire Biomedical based inDallas, TEXAS (USA)
A Revolutionary Virtual Care and Prescription Drug Management System designed to become the Standard-of-Care in Personalized Medication ...
Manufactured by:Portal Instruments, Inc. based inCambridge, MASSACHUSETTS (USA)
A revolutionary and unprecedented advancement in biologic administration; Our needle-free drug delivery system is designed to administer a narrow stream of medication, about the size of a strand of hair, through the skin in less than half a ...
Manufactured by:Medimpex United Inc. based inBensalem, PENNSYLVANIA (USA)
The 14 Panel T-Cup Drug Test Cup with Adulteration is an advanced urine drug screening tool designed specifically for comprehensive and efficient drug monitoring. It is FDA and CLIA waived, emphasizing its compliance with medical standards and easy adoption in various settings. This test cup detects a wide range of substances, ...
by:DEARGEN Inc. based inDaejeon, SOUTH KOREA
MolEQ designs novel compounds by optimizing multiple properties such as efficacy and toxicity of a lead ...
Manufactured by:Addex Therapeutics based inGeneva, SWITZERLAND
Dipraglurant is a novel orally available highly selective metabotropic glutamate receptor subtype 5 negative allosteric modulator (mGlu5 NAM) which has completed Phase 1 and demonstrated efficacy in a Phase 2a proof of concept study for the treatment of levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). This is a disease with significant commercial opportunity as ...
Manufactured by:SQ Innovation, Inc. based inBurlington, MASSACHUSETTS (USA)
Lasix ONYU is an advanced prescription drug-device combination designed specifically for the treatment of edema in adults suffering from chronic heart failure. This innovative product represents a shift from traditional oral and intravenous methods by introducing a high-concentration formulation of furosemide for subcutaneous infusion. ...