FDA Grants Breakthrough Designation to Amgen’s Cancer Antibody Drug
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 study...
New Oral Contraceptive Called NEXTSTELLIS Approved by FDA
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...
FDA’s ACIP Requires More Data for J&J COVID-19 Vaccine Decision
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 potentially...
Illuminare-1 Granted IND Approval by FDA for First-In-Human Trial
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...
FDA Grants Second Approval for Gilead’s Trodelvy
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...
FDA Approves of Revolutionary AI Device for Colonoscopy
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....
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