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Drug Approval Articles & Analysis
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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, ...
This finding underscores the need to reduce plastic usage, especially with hot foods, to minimize health risks. 2. A New Drug to Reduce Heart Attacks and Strokes The newly approved drug Sotagliflozin (Inpefa) has shown promise in reducing heart attacks and strokes among patients with type 2 diabetes and chronic kidney disease. ...
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. ...
In the realm of medicine, recombinant cytokines are increasingly being utilized as therapeutic agents for a variety of diseases, including cancers, infections, and hematopoietic disorders. These biological drugs have shown promise due to their effectiveness at low doses and relatively mild side effects compared to traditional pharmaceuticals. Currently approved ...
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 ...
With the approval of many antibody-drug conjugation (ADC) drugs around the world since 2019, conjugate drugs have developed into one of the hottest tracks in the pharmaceutical industry. ...
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. ...
Based on the needs above, current ionizable cationic lipids approved by Food and Drug Administration, such as DLinMC3-DMA (MC3), ALC-0315, and SM-102, do not meet the requirement of "biodegradable". ...
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. ...
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 ...
Loading the liposomes There are two main ways to load drugs into liposomes: Passive loading: This involves mixing the drug with the phospholipids during liposome formation. Hydrophilic drugs stay in the aqueous core, while hydrophobic drugs integrate into the lipid bilayer. ...
Antibody drug conjugates (ADCs) are a new class of biopharmaceuticals that use monoclonal antibodies to target tumor cells to deliver potent cytotoxic drugs. So far, a total of 15 ADC drugs have been approved worldwide, of which the FDA has approved 13 ADCs for various cancers, including Adcetris®, Kadcyla®, ...
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. ...
At the same time, a variety of design functions can be integrated and flexibly adjusted via DPC, which is expected to play a unique role in the delivery of siRNA drugs. GalNAc-siRNA GalNAc-siRNA is a stable conjugate formed by the covalent conjugation of GalNAc to the 3' end of the sense sequence of siRNA. ...
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 ...
Antibody drug conjugate (ADC) research involves more and more targets, such as HER-2, Trop-2, Claudin-18.2, B7-H3 and B7-H4, etc. ...
Multiple clinical trials are currently underway to test new therapies for CF, including gene therapy and drugs targeting specific mutations in the CFTR gene. In addition, researchers are exploring new methods, such as CRISPR genome editing, to treat CF at the gene level. ...