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Drug Approval Articles & Analysis
42 articles found
Current therapies for IPF rely on oral administration of pirfenidone and nintedanib, two FDA-approved drugs that slow disease progression. While effective, oral dosing requires high systematic concentrations, which often lead to gastrointestinal side effects and liver toxicity. A targeted approach that delivers these drugs directly to the lungs ...
One such approach involves the repositioning, or repurposing, of drugs already FDA approved in either non-oncology disease states and/or approved in a limited number of tumor types. The repurposing of these drugs for new indications represents an opportunity to circumvent the time and investment that must go into the discovery, ...
Absorption refers to how a drug is absorbed into the bloodstream after administration. Factors influencing this process include the drug’s solubility, chemical stability, and the route of administration. ...
Role of Liposomes in Drug Delivery The structure of liposomes, consisting of an aqueous core enclosed by a lipid bilayer, allows for the encapsulation of both hydrophilic and lipophilic drugs. ...
Clinical trials are the backbone of modern medicine, responsible for bringing innovative, safe, and efficient treatments to market after rigorous testing and evaluation. However, the conventional process of conducting these trials has often been long, expensive, and fraught with inefficiencies¹. The advent of predictive analytics is reshaping the landscape of clinical trials, ushering in a ...
One critical element in the drug development process is drug metabolism and pharmacokinetics (DMPK), which refers to how a drug is absorbed, distributed, metabolized, and excreted (ADME) from the body. ...
The most reliable way to detect HP is to use this non-invasive 13C-UBT method, which can infer H. pylori in the stomach by detecting the 13C/12C isotope ratio in the exhaled gas after oral administration of 13C-urea. Drug Metabolism Study The study of drug metabolism in the body is a very critical process for the development of new drugs, and the ...
The catabolism of this structure causes Lys-SMC-DM1 to become the main tumor metabolite. Furthermore, drugs linked to this linker usually cannot exert bystander effect because the released catabolites are less permeable. ...
Despite its crucial role as a versatile building block in drug discovery, the formation of DKP reactions is highly undesirable in the production of peptide drugs. ...
One critical element in the drug development process is drug metabolism and pharmacokinetics (DMPK), which refers to how a drug is absorbed, distributed, metabolized, and excreted (ADME) from the body. ...
Beyond these obstacles, the number of antifungal drugs approved for treatment is limited, and many of them are known to cause severe side effects.Despite these challenges, there was a breakthrough in antifungal peptide drugs in the first quarter of 2023. On March 22, 2023, the FDA approved Rezzayo™ (intravenous rezafungin) for ...
Most of the clotting factors used for the treatment are obtained from human plasma however, in 1992 the U.S. Food and Drug Administration first time approved a genetically engineered recombinant factor VIII. ...
The FDA's Center for Drug Evaluation and Research (CDER) regulatory approval of a total of 26 NME (New Molecular Entity) drugs in the first half of 2023. It is worth noting that the 26 drugs approved include 4 peptide drugs, accounting for 15% of the total. ...
Minoxidil was first introduced by Upjohn Company of the United States, and was first used as an oral drug for the treatment of refractory hypertension in the 1970s. In later clinical applications, doctors observed hair regrowth and generalized excessive hair in balding patients, which led to the development of minoxidil preparations. Minoxidil can increase local blood supply, ...
Antibody drugs are generally more specific and selective than traditional chemical drugs, reducing unnecessary side effects and toxicity. Additionally, antibody drugs can also be used in combination with other drugs to enhance their therapeutic efficacy and bioavailability. ...
In the fast-paced realm of drug discovery, scientists constantly seek innovative approaches to efficiently and cost-effectively identify potential drug candidates. ...
T-DM1(Ado-trastuzumab Emtansine) T-DM1 is the first ADC drug to target HER2-positive breast cancer. T-DM1, which is bound by trastuzumab and tubulin inhibitor DM1 via a stable, non-lytic, non-reducing thioether linker, was first approved by the FDA in 2013 for use in advanced breast cancer patients with HER2-positive metastases or who have been treated with ...
Drug-to-antibody ratio (DAR, drug-to-antibody ratio) The number of cytotoxic drugs connected to each antibody is the drug-to-antibody ratio (DAR). When the DAR increases, the drug metabolism rate of ADC drugs increases, the half-life decreases, and the systemic toxicity increases. ...
On February 24, 2023, The NMPA approved Enhertu, an injectable drug developed jointly by AstraZeneca and Daiichi Sankyo, for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 drugs. ...
The Brisbane-based designer of the world’s smallest orthopaedic screw has invoiced US hospital suppliers $900,000 in the three weeks since the device gained Food & Drug Administration approval, and he hopes it can soon be made in Brisbane too. ...