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Drug Administration Articles & Analysis
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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 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). ...
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. ...
In addition to a variety of experimental animals including mice, rats, rabbits, and monkeys, Ace Therapeutics can assist worldwide clients in constructing custom animal models using techniques such as environmental enrichment, gene editing, dietary modifications, or drug therapies. Moreover, the company can also provide researchers with cardiac organoid models and human induced ...
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. ...
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 ...
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. ...
In response to our positive initial data, the US Food and Drug Administration (FDA) awarded our HLHS program with three distinct and important designations: Rare Pediatric Disease designation, Orphan Drug designation, and Fast Track designation, each of which offer benefits to our development and regulatory processes. ...
This cutting-edge drug delivery system is poised to revolutionize medication administration, offering patients a more convenient and effective treatment method. ...
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. ...
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 moment in the industry. ...
The new Anuncia Medical implant is called the ReFlow Mini Flusher and was recently cleared by the Food & Drug Administration (FDA), to noninvasively improve, restore and maintain flow in hydrocephalus brain shunts. ...
Microneedles are tiny, painless needles that penetrate the skin's outer layer, enabling the delivery of drugs into the underlying tissues. This approach offers several advantages over traditional methods, such as increased drug absorption and easier administration. ...
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 ...
“The data shared today validate our clinical efforts to advance cebranopadol and reinforce the potential of this investigational therapy to contribute to a future where pain can be managed without further exacerbating the impact of drug addiction.” HAP studies are required prior to U.S. Food and Drug Administration (FDA) approval in ...
By encapsulating pharmaceutical agents within these microspheres, CD Formulation enables precise dosage delivery, which can help reduce the frequency of drug administration. The company's microsphere manufacturing technologies cover a wide range of aspects, including membrane emulsification and sedimentation technology, microfluidic technology, membrane ...
In chronic kidney disease associated with type 2 diabetes, based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization by the U.S. Food and Drug Administration (FDA), the European Commission, and the Chinese National Medical Products Administration (NMPA). ...
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