India Sets New World Record of COVID-19 Cases
India recorded today the highest number of COVID-19 cases in a day today (4/22) at 314,835 infections, surpassing the previous record from the United States at 297,430. The exponential rise in cases have caused fear regarding hospital oxygen supply levels to treat...
Pipeline™ Flex Embolization Device with Shield Technology™ Receives FDA Approval
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...
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...