The U.S. Food and Drug Administration (FDA) granted Medtronic’s Pipeline™ Flex Embolization Device with Shield Technology™ regulatory approval. The Shield Technology is designed to introduce the first surface-modified implant device that reduces the tendency of...
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...
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...
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...
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...
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...
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