Jun 1, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has given Amgen’s Lumakras (sotorasib) accelerated approval as a treatment for patients diagnosed with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) – the first FDA approved...
Mar 5, 2021 | Clinical Trials, EMA, FDA, Health, Linguistic Validation, Medical Translation
Over the last several years, patient-centricity has been a key theme in the healthcare sphere for improving drug therapies and medical devices for patients all around the world. To better serve patients, life science companies are putting in more effort on listening...
Aug 31, 2020 | News, Regulatory
Gilead, a research-based biopharmaceutical company, has reported that their new antiviral treatment for COVID-19 Remdesivir, has just been granted an expansion on emergency use authorization (EUA) by the FDA for all patients hospitalized due to COVID-19. Originally...
Jul 17, 2020 | News, Regulatory
The European Commission (EC) has granted approval for Novartis’ Enzair Breezhaler, a medicine for uncontrolled asthma. The drug therapy is utilized as a maintenance treatment for adults with asthma. “Novartis is working to reimagine medicine for people with...
