Apr 8, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has granted Donisi De Novo clearance for its contact-free multiparameter measurement system. The innovative system is backed by 26 patents and consists of a combination of artificial intelligence (AI), algorithms, and...
Apr 7, 2021 | Medical Translation, News, Regulatory
Eli Lilly and Incyte’s atopic dermatitis drug received extended supplemental New Drug Application (NDA) review by the U.S. Food and Drug Administration (FDA) for baricitinib, a drug therapy intended for patients with moderate-to-severe conditions. The extension...
Apr 6, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Respinova to market their device that clears secretions for patients with respiratory issues by facilitating the opening of airways. The device, called Pulsehaler, is the first to use patented...
Apr 5, 2021 | News, Regulatory
The European Commission has granted Orphan Designation for PBKR03, a treatment from Passage Bio to treat Krabbe disease. Krabbe disease is a rare lysosomal storage disorder that currently does not have any approved disease-modifying treatments. The approval comes...
Apr 2, 2021 | News, Regulatory
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is “intended to make the European pharmaceutical system patient-centered, future-proof and...
