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Drug Application Articles & Analysis
161 news found
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. ...
An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. ...
Biopharma PEG, a leading manufacturer of high-quality polyethylene glycol (PEG) derivatives, today announced that its mPEG-pAld (20K) product has successfully achieved DMF (Drug Master File) registration with the U.S. Food and Drug Administration (FDA) under DMF number 040600. ...
(Huateng Pharma), a global leader in the development and production of high-quality PEG derivatives, is pleased to announce that its mPEG-pALD (20K) has successfully completed its Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA), under DMF No. 040600. ...
This special offer is valid through December 4, 2024, at 23:59 EST.Our monodispersed PEGs are highly versatile and indispensable in various pharmaceutical and biotechnological applications. These precision-engineered compounds are widely used in PEGylation, a process that enhances the pharmacokinetics and stability of therapeutic molecules. They are also critical components in ...
In the rapidly evolving landscape of pharmaceutical innovations, CD Formulation emerges as a key player, offering customized drug conjugates services that cater to the rising demands for advanced drug development. ...
Among the various materials used in medical device design, polytetrafluoroethylene (PTFE tubing) has emerged as a standout choice, particularly in applications such as catheters and drug delivery systems. This article explores the role of advanced materials like these in driving innovation in medical devices, focusing on their benefits and implications for the ...
CD Bioparticles, a leading manufacturer and supplier of numerous drug delivery products and services, has recently expanded its low PDI polymer portfolio and announces its new offering of Polyolefin Family polymers with a wide range of properties that make them well-suited for a variety of drug delivery applications. ...
Boston: Microneedle technology, driven by high demand in dermatologic procedures and its versatile applications in drug delivery, vaccine administration, and disease diagnostics, faces challenges in its complex manufacturing process. ...
The screening of substrates, inhibitors, and other ligands is a pivotal facet of enzyme research, enabling scientists to pinpoint compounds best suited for a variety of applications, from drug development to industrial processes. A profound understanding of enzyme-molecule interactions can pave the way for groundbreaking therapies, improved bioprocessing, and the ...
This cutting-edge technology provides scientists and researchers with an innovative platform to study human organs in a way that was previously impossible, promising to accelerate drug discovery, reduce the need for animal testing and ultimately transform the future of medicine. ...
CARLSBAD, Calif., March 7, 2023 /PRNewswire/ -- Ionis Pharmaceuticals (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for eplontersen, an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid ...
The ultra- sensitive plate reader, CLARIOstar®, will analyze rapid beat-to-beat changes (up to 50 Hz) in the fluorescence intensities of dyes that indicate physiological states in engineered 3D heart tissue after drug/compound application. In addition, InvivoSciences, Inc. is sponsoring a workshop during Cell Based Assays Summit in Munich Germany, December ...
This improved outlook comes amid the company’s potential blockbuster drugs tracking ahead of schedule and targeted investments in Research and Development (R&D) replenishing its pharmaceutical development pipeline. ...
ByBayer AG
Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD). ...
“Antengene believes that cancer treatments involving the rational combination of immuno-oncology drugs and targeted therapies may offer the greatest opportunity for substantial advances in treatment outcomes for patients with cancer,” said Dr. ...
Shanghai and Hong Kong, PRC, December 23, 2022 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has submitted New Drug ...
(Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer ...
Molecular Devices, LLC., a leading provider of high-performance life science solutions, today announced the acquisition of Cellesce Ltd (“Cellesce”) which specializes in contract development and manufacturing of large scale patient-derived organoids (PDOs) for diverse applications, including drug screening. Drug efficacy and toxicity ...
Terray Therapeutics, a biotechnology company accelerating drug discovery through the application of computational approaches to precisely generated chemical data at scale, today announced the appointment of Bassil Dahiyat, Ph.D., as an Independent Director. ...