Drug Approval Equipment & Supplies
103 equipment items found
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: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 ...
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: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 ...
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: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:Amivas (US), LLC based inFrederick, MARYLAND (USA)
Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adults and ...
Manufactured by:EndoLogic LLC based inClifton, NEW JERSEY (USA)
Renzapride is best suited as a treatment of Diabetic Gastroparesis, a condition with a significant unmet treatment options. In the numerous trials that have been done using Renzapride more than 5000 patients have been treated with Renzapride. An extensive cardiac safety evaluation under the FDA mandated Thorough QT trial has shown that Renzapride does not have any cardiac safety ...
Manufactured by:BioQ Pharma based inSan Francisco, CALIFORNIA (USA)
invenious connect-and-go technology is already being used to deliver infusibles in a patented range of infusion systems. Our products are thoughtfully-designed to each drug – with bespoke solutions for: Drugs requiring complex weight-based dosing. Cytotoxic drugs. Drugs that need to be reconstituted or diluted at time of use. Drug-drug combinations, including for cold-chain ...
Manufactured by:Inoviem Scientific SAS based inIllkirch-Graffenstaden, FRANCE
Identify the mode of action of your compound with NPOT® technology; NPOT technology is a unique heterogeneous assembly method for conducting extensive identification of all proteins (together with their native structure) involved in drug-target ...
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:Catalent, Inc based inSomerset, NEW JERSEY (USA)
GPEx cell line development technology is a proven technology that generates high-performance, highly stable, production cell lines. Virtually any cDNA (mAb and multigenic applications) can be inserted into cells. To date, over 600 different mAb and mAb fusions and over 160+ different recombinant proteins have been produced using the GPEx system, with 160+ clinical trials utilizing therapeutic ...
Manufactured by:Auro Vaccines LLC based inPearl River, NEW YORK (USA)
Auro Vaccines has developed VesiculoVax™-vectored vaccines for pre- and post-exposure protection against the hemorrhagic disease caused by multiple species of filovirus (i.e. Zaire ebolavirus, Sudan ebolavirus and Marburg ...
by:Pureims B.V. based inRoden, NETHERLANDS
Amikacin Cyclops™ is an amikacin dry powder inhaler for the treatment of tuberculosis (TB). Inhaled amikacin from the Cyclops™ will result in higher amikacin concentrations in the lungs than conventional infusion or intramuscular injection. This could more rapidly decrease contagiousness by sterilizing the upper airways of patients with ’open’ (smear positive) TB, ...
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:UroGen Pharma, Inc. based inPrinceton, NEW YORK (USA)
UroGen is developing UGN-102 (mitomycin) for intravesical solution as a primary nonsurgical alternative to repetitive TURBT. UGN-102 is an investigational formulation that utilizes our innovative technology, RTGel™ reverse-thermal hydrogel, for the treatment of low-grade NMIBC. Instilled via standard catheters, UGN-102 is designed to dwell for a period of several hours before being excreted ...
Manufactured by:Trudell Medical International based inLondon, ONTARIO (CANADA)
For use with Metered Dose Inhaler (MDI/pMDI) by drug manufacturers. The 1st FDA approved dose counter for MDI developers and the leading choice for your inhalation drug development product. The AERCOUNT* Dose Counter provides patients with a visual indication of remaining medication in their pressurized Metered Dose Inhaler (MDI) and is currently ...
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 ...
Manufactured by:Jericho Sciences, LLC based inDurham (RTP), NORTH CAROLINA (USA)
Jericho is developing a new therapeutic drug for FIV infection in cats, working toward a New Animal Drug Application (NADA) with the FDA. Our ongoing studies indicate that Jericho’s small molecule drug candidate can reduce FIV virus levels in chronically-infected cats for many months in the absence of continuing treatment. Extensive testing also indicates that the drug candidate has a good ...
Manufactured by:Lipella Pharmaceuticals Inc. based inPittsburgh, PENNSYLVANIA (USA)
Hemorrhagic Cystitis, also called Radiation Cystitis when occurring after pelvic radiation. Lipella is currently conducting a phase-2a, dose-escalation clinical trial evaluating LP-10 (liposomal tacrolimus) for the treatment of hemorrhagic cystitis. Lipella has received US-FDA Orphan Designation for this developmental product. Radiation used to treat prostate, colon, uterine, cervical and other ...