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Drug Approval 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. ...
Proregulations is familiar with the MAA approval process, provides detailed interpretation and advice on EU drugs regulations, and develops application strategies for specific products and needs. ...
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 ...
Watertown, MA — October 24, 2024 — Biopharma PEG is excited to announce its extensive offerings of polyethylene glycol (PEG) products, including monofunctional, homobifunctional, heterobifunctional, and multi-arm PEGs, tailored for PEGylation in biopharmaceutical applications. With over 40 PEGylated drugs approved globally, the role of PEGylation in ...
CanaQuest Medical Corp (“CanaQuest” or the “Company”) (OTC: CANQF), is pleased to announce strategic additions to its executive team with expertise in conducting clinical trials and US FDA drug approval success. The team plans to effectively navigate the regulatory approval process for Drug Candidate, ...
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
Over the past two decades, the biopharmaceutical market has expanded, with monoclonal antibodies exhibiting a 26 percent higher approval rate than other drugs. The market value of monoclonal antibodies alone is expected to reach more than $300 billion USD by 2025. ...
“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 ...
An increasing number of clinical trials in the field of viral vector therapy and viral vector manufacturing, confirms the value of this new medicinal technology, and several viral vector-based drugs have also been globally approved. Therefore, these vectors represent a promising strategy e.g., against emerging diseases such as Covid-19. ...
ByNuvonis
The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line ...
VeriSIM Life has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $255,908 to conduct research and development (R&D) work on rapid repurposing and translation of approved and investigational drugs for COVID-19 using its patented artificial intelligence (AI) driven biosimulation platform, BIOiSIM. ...
As founding Chief Scientific Officer (CSO) at Moderna Therapeutics, he pioneered modified mRNA as a new therapeutic and vaccine drug modality and the mRNA chemistry and delivery systems that form the basis of the approved COVID-19 mRNA vaccines. Prior to that, as VP of Research at Alnylam, he helped develop RNA interference (RNAi) as a new drug ...
ByeTheRNA
“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 ...
(“BRIM,” TPEx 6885) is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye disease which causes very severe cornea damage and can lead to loss of sight. ...
The medical sterilization bag is a medical device approved by the Food and Drug Administration. The appearance of the sterilizing bag must be able to penetrate the sterilizing agent and provide protection during handling and storage. ...
Management will discuss the Company’s neuroscience and immuno-oncology programs as well as its artificial intelligence platform used to augment and accelerate the drug candidate discovery and development process. They will also discuss the Company’s ongoing commercial launch strategy for IGALMI™ (dexmedetomidine) sublingual film. ...
Pronalyse is a subdivision of Creative Proteomics, an integrated CRO company with rich experience in providing drug development services. Building on its years of experience, Creative Proteomics Pronalyse announces the launch of its fusion proteins characterization service to ensure the production of safe and effective therapeutic fusion proteins. ...
This strategic trial design follows a Type B meeting with the U.S. Food and Drug Administration and observed dose-dependent responses in a prior Phase 1/2b study assessing a range of doses. ...