Jul 30, 2021 | News, Regulatory
The European Commmision (EC) has granted Bristol Myers approval for Opdivo (nivolumab) to treat adult esophageal or gastroesophageal junction (GEJ) cancer who have pathologic disease after previous neoadjuvant chemoradiotherapy (CRT). With the approval based on the...
Jul 26, 2021 | News, Regulatory
Health Canada has granted BeiGene approval for BRUKINSA (Zanubrutinib) to treat mantle cell lymphoma (MCL) in adults who have already received at least one other prior treatment. As global, science-driven biotechnology company, BeiGene focuses on improving treatment...
Jul 19, 2021 | News, Regulatory
Johnson & Johnson is recalling Neutrogena Beach Defense and Ultra Sheer sunscreens after elevated levels of benzene were detected. Benzene is a chemical compound that, over long term and frequent exposure via skin contact or inhalation, can cause serious health...
Jul 16, 2021 | News, Regulatory
Ipsen, a global pharma company, and IRLAB, a Swedish research and development business, have entered an exclusive licensing agreement for Ipsen to commercialize mesdopetam, a dopamine D-3 receptor antagonist taken orally to improve the quality of life for patients...
Jul 14, 2021 | News, Regulatory
The Medical Device Coordination Group (MDCG), part of the European Commission, has provided a guidance document navigating the use of codes under the In Vitro Diagnostic Regulation (IVDR). The codes are used to describe the qualifications of both the notified body...
