March 25, 2024
Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), at least 24 months after the issuance of a final guidance document in […]
March 25, 2024
Reference #: FEI 3006441852 Product: Drugs Recipient: Recipient Name Nathan Trembath Recipient Title General Manager Abraxis Bioscience LLC 620 N 51 St. Ave.Phoenix, AZ 85043United States […]
March 25, 2024
Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Mr. Giovanni Caforio Recipient Title Chief Executive Officer Abraxis Bioscience LLC 620 N 51st Ave.Phoenix, […]
March 25, 2024
[03/25/2024] FDA’s Center for Drug Evaluation and Research (CDER) is pleased to announce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE). QM involves the development […]
March 25, 2024
On This Page Date: April 25, 2024 Time: 9:00 AM – 1:00 PM ET Location Zoom About This Event: This virtual workshop will be hosted by […]
March 25, 2024
A next-generation multitarget stool DNA (mt-sDNA) test for colorectal cancer (CRC) screening had higher sensitivity for all screening-relevant lesions but lower specificity than a currently available […]
March 25, 2024
The US Food and Drug Administration granted full approval to mirvetuximab soravtansine-gynx (Elahere) for adults with folate receptor alpha–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary […]
March 25, 2024
(Reuters) -Regeneron Pharmaceuticals said on Monday the U.S. FDA has declined approval for its blood cancer therapy for two forms of lymphoma on concerns over the […]
March 25, 2024
TOPLINE: Changes to retinal blood vessels may be an indicator of development of preeclampsia, according to a poster presented at the 2024 meeting of the Society […]