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Hardy Diagnostics, a medical device manufacturer based in Santa Maria, California, announced FDA EUA approval on April 24th for a new in vitro diagnostic medical device: Anti-SARS-CoV-2 Rapid Test (Cat. No. RTA0203). This immunoassay is intended for qualitative detection and...

Who would have thought a pandemic in this modern era would cripple the world, the strongest economies would be shaken, and end up being so vulnerable despite having the most modern technologies and processes at our disposal. That being...

BioLab Sciences, a regenerative biotechnology company, announced they are now distributing tests to detect antibodies specific to 2019n-CoV in humans. The test devices complete the screening using a blood sample from a finger prick and produce results in 10...

Abbott announced that the U.S. FDA has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in...

Early phase bioequivalence studies are/can be conducted on all USFDA Orange book approved list of dosage forms based on submission requirements by pharmaceutical companies This has been a market trend for more than 2 decades. USFDA Orange book lists nearly...

As a noticeable shift occurs in the pharmaceutical industry from blockbuster drugs to smaller patient populations, there is an increased focus on targeted therapies in specialized areas, such as oncology, where potent compounds serve a key role in patient...

An ageing population, patent expirations, growth of disease prevalence, and expensive breakthrough therapies are driving demand for the development of many new pharmaceutical products. These growing pressures mean that pharmaceutical developers are faced with rising R&D costs and the...