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Drug Application And Tudorza Supplemental New Drug Application Articles & Analysis
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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. The MAA is complicated by the need to consider both European economic integration and the independence of individual member states. As a specialist in regulatory matters, Proregulations has ...
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. “We are thrilled to receive FDA DMF registration for our mPEG-pAld (20K) product,” said Sonia Lee, Marketing ...
Changsha, China – Hunan Huateng Pharmaceutical Co., Ltd. (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 achievement highlights Huateng Pharma’s ...
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. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but ...
Watertown, MA — November 25, 2024—In the spirit of Thanksgiving, Biopharma PEG Scientific Inc. would like to express its sincere gratitude to our esteemed customers and partners for their trust and support. It is a privilege to collaborate with you, and we look forward to further strengthening our partnership in the future.As a gesture of our appreciation, we are pleased to announce a 30% ...
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. Specializing in complex biologic formulations, Biologics & Biosimilars service team of CD Formulation is revolutionizing how drug conjugate products are conceptualized and produced, ...
The medical device industry is undergoing a transformative period marked by groundbreaking innovations and advanced materials. As healthcare continues to evolve, the need for devices that enhance patient outcomes while ensuring safety and reliability is more critical than ever. Among the various materials used in medical device design, polytetrafluoroethylene (PTFE tubing) has emerged as a ...
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. Low dispersion index polymers are polymeric compounds with low molecular weight ...
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. Ongoing research and numerous products in development make this market dynamic for newcomers entering the field. “According to the latest BCC Research study, ...
Creative Enzymes, an esteemed frontrunner in the field of enzyme-related solutions, is excited to introduce an innovative suite of screening services designed to cater to the evolving needs of today's scientific community. In the ever-changing realm of scientific research, the importance of comprehensive and dependable screening for substrates, inhibitors, and ligands has become increasingly ...
In a groundbreaking move to revolutionize the field of biomedical research, Alfa Chemistry recently announced the launch of its highly anticipated custom organs-on-chips service. 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 ...
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 polyneuropathy (ATTRv-PN). The application has been given ...
The Microplate Reader Company – and InvivoSciences, Inc. – a leader in stem cell tissue engineering providing a novel solution in first-in-class drug discovery – announced today a strategic collaboration to market the time-dependent fluorescent assessment of engineered 3D heart tissues using advanced microplate reader technologies. Employing an automated system, 3D heart ...
Company to Host Investor and Business Development Meetings Adjacent to Upcoming J.P. Morgan Healthcare Conference in San Francisco Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced the ...
ATG-037 is Antengene’s oral small molecule CD73 inhibitor; KEYTRUDA® (pembrolizumab) is MSD’s anti-PD-1 therapy The clinical trial collaboration will focus on evaluating ATG-037 as a monotherapy and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors The study of ATG-037 monotherapy started enrolling patients in Q2 2022 and will ...
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 Applications ...
Additional indication is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations Represents the fifth indication for PEMFEXY, a ready-to-use liquid with a unique J-code approved to treat non-squamous non-small cell lung cancer and mesothelioma Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” ...
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 testing often rely on immortalized cell lines or ...
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. “We are incredibly fortunate to have Bassil join the Terray team,” said Jacob Berlin, Ph.D., Chief Executive Officer of Terray. ...
Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported Newly presented data offered additional insight into the SKYLARK Study and further demonstrated the rapid improvements in depressive symptoms observed in the clinical ...