Apr 20, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) awarded Amgen’s cancer antibody drug, bemarituzumab, Breakthrough Therapy Designation for a first-line treatment for specific kinds of gastric cancer. The decision comes after the FDA reviewed data from Phase II FIGHT...
Apr 19, 2021 | News, Regulatory
NEXTSTELLIS, the first and only oral contraceptive pill containing E4, has been approved by the U.S. Food and Drug Administration (FDA). E4 is a naturally occurring estrogen that is now being produced from a plant source, and differs from other estrogens as a Native...
Apr 16, 2021 | News, Regulatory
The U.S. Food and Drug Administration’s (FDA) Advisory Committee on Immunization Practices (ACIP) met on April 14 to provide its recommendation regarding the pause of the Johnson & Johnson COVID-19 vaccine due to the association of extremely rare but...
Apr 15, 2021 | Clinical Trials, Health, Healthcare
Patient centricity and patient diversity are two trends that have taken the life science sector by storm. Simply put, patient centricity is defined as “designing a treatment, clinical trial, or other health solution centered around the patient”. Patient diversity, on...
Apr 15, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) granted Illuminare-1 Investigational New Drug (IND) approval for the first-in-human trial at Memorial Sloan Kettering Cancer Center (MSK). Illuminare-1 is a small molecule, myelin binding agent that is meant to improve the...
Apr 14, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) granted accelerated approval for Trodelvy, a drug therapy for patients with locally advanced or metastatic urothelial cancer (mUC), an aggressive disease with a survival rate of 5.5%. Previously, Trodelvy was granted...
Apr 12, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) announced de novo clearance of GI Genius™, a revolutionary AI device for colonoscopy. The device is the first of its kind, and was developed by Cosmo Pharmaceuticals, with exclusive distribution rights to Medtronic....
Apr 9, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) announced today an actionable plan, called Closer to Zero, to reduce the exposure of toxic elements in foods commonly consumed by babies and young children. While FDA’s testing results have shown that there is no...
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...
