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June 02, 2020
Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
May 28, 2020
Virpax Pharmaceuticals, which specializes in developing pharmaceutical products for pain management using novel drug delivery systems, has announced the successful completion of a pre-investigational new drug (IND) application meeting with the US FDA.
The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.
May 21, 2020
The Trump Administration has awarded a hefty contract to a new pharmaceutical manufacturing consortium to produce in the United States all components of certain critical medicines needed to combat COVID-19.
May 18, 2020
The European Medicines Agency is emphasizing the need for the research community to pool resources to determine which COVID-19 treatments and preventions are safe and effective.
May 15, 2020
A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.
A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.
May 14, 2020
The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.
May 08, 2020
The agency is responding to companies promoting and selling medical products that claim, but are unproven, to prevent or treat COVID-19.
May 07, 2020
A rolling review of data on the use of remdesivir, an investigational antiviral medicine, for the treatment of COVID-19 has been started by EMA’s Committee for Medicinal Products for Human Use.