Refine by
Drug Enforcement Administration Articles & Analysis
816 news found
Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. The assigned DMF number is 041864. This significant achievement underscores Biopharma PEG's robust ...
The Food and Drug Administration’s (FDA) recent Roadmap to Reducing Animal Testing in Preclinical Safety Studies marks a pivotal shift toward the adoption of innovative, human-relevant methodologies commonly known as New Approach Methodologies (NAMs). As leaders in preclinical research tools, we welcome this movement towards advanced and validated NAMs solutions already in place. emka ...
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 ...
Ace Therapeutics is proud to announce the launch of its cardiovascular disease model development services, aiming to empower researchers and pharmaceutical companies with advanced tools and models to accelerate the study of cardiovascular diseases and drug discovery. Cardiovascular disease (CVD) remains a leading cause of morbidity and mortality worldwide, underscoring the urgent need for ...
“In a unanimous ruling, the U.S. Supreme Court today rejected a lawsuit challenging the regulatory approach of the Food and Drug Administration on mifepristone, a vital medication used in medication abortion procedures. This ruling is a win for reproductive rights amid continued attacks on abortion access. Mifepristone has been proven to be a safe and effective method for terminating ...
Tempus, a leader in artificial intelligence and precision medicine, announced new testing solutions to help physicians identify patients with HER2 or FOLR1 expressing tumors, which may make such patients eligible for targeted therapies such as antibody–drug conjugates (ADCs). HER2 and FOLR1 testing by immunohistochemistry (IHC) is now available for all solid tumor cancers as an ...
ByTempus
CD Formulation, a leading pharmaceutical contract service company, has recently unveiled groundbreaking hydrogel microneedle patch technology aiming at increase the drug loading capacity and enhance drug delivery efficiency. The new technology represents a significant advancement in the field of transdermal drug delivery. The hydrogel microneedle patch consists of a patch with tiny microneedles ...
Investorideas.com (www.investorideas.com) Biotech Stock News Bites - Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines is one of NASDAQ's top gainers today and the stock is trending on Yahoo Finance, currently trading at $3.8955, up $1.6955 or 77.0682%. The stock had a morning high of $5.47 on volume of over 36 Million/. The Company's CEO, ...
In a groundbreaking development in the field of pharmaceuticals, CD Formulation, a prominent drug formulation company, has announced the launch of Oral Thin Film Technology. This cutting-edge drug delivery system is poised to revolutionize medication administration, offering patients a more convenient and effective treatment method. Oral Thin Film Technology is a user-friendly drug delivery ...
Advancements in drug delivery technology have paved the way for more efficient and targeted treatment options. Among these innovations is the development of coated microneedle preparation technology, which has shown promising results in delivering novel drugs to patients. CD formulation involves coated microneedles with specific drug compounds, allowing for controlled and sustained drug delivery. ...
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, ...
Stem cell therapy is a groundbreaking field in the pharmaceutical industry, offering powerful tools for treating severe diseases such as cancer. The genetic manipulations involved in this process, however, necessitate stringent regulations to ensure sterility and safety. In 2017, the Food and Drug Administration (FDA) took significant steps towards regulating stem cell therapy, marking a pivotal ...
Surgeons at Intermountain Primary Children’s Hospital are the first in the nation to successfully implant a new brain shunt accessory for young patients with hydrocephalus, a neurological condition that causes a buildup of cerebrospinal fluid in the deep cavities of the brain that often causes frequent hospitalizations. This extra fluid puts pressure on the brain and can cause brain ...
In the ever-evolving field of pharmaceuticals, CD Formulation has emerged as a major player in developing innovative drug delivery systems aimed at enhancing the efficacy and safety of therapies. Through its expertise in various cutting-edge technologies such as microneedle and thin film technologies, transdermal patches, microencapsulation, and nanoparticle development, CD Formulation is ...
The U.S. Food and Drug Administration (“FDA”) has announced a new medical device product classification “whole room microbial reduction device” which establishes FDA regulation of UV robots intended to reduce the number of pathogens in unoccupied patient rooms, operating rooms and other areas in healthcare facilities where non-critical ...
Positive results confirm findings from prior studies evaluating the abuse potential of cebranopadol, further highlighting its potential as a safe and potent alternative to traditional opioids Registrational phase 3 clinical trials of cebranopadol in moderate to severe acute pain are on track to initiate in Q4 2023 – Business Wire – Tris Pharma, Inc. (Tris), a commercial-stage ...
As medicine continues to advance in this new era, drug delivery methods have been revolutionized to enhance patient comfort, improve treatment outcomes and ensure effective delivery of therapeutic compounds. CD Formulation, a leading pharmaceutical research and development company, has recently unveiled a series of cutting-edge technologies that will further revolutionize and redefine the realm ...
Phase III study FINE-ONE will evaluate the efficacy and safety of finerenone versus placebo in delaying the progression of chronic kidney disease (CKD) in adults with CKD and type 1 diabetes (T1D) CKD affects up to 40% of people with T1D A quarter of people with CKD associated with T1D progress to end-stage kidney disease Only limited treatment options are available for people with CKD and ...
ByBayer AG
The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis management that aims to uncouple efficacy from ...
ByBayer AG