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February 2, 2023

FDA Approves Daprodustat, First Oral Anemia Treatment FDA Approves Daprodustat, First Oral Anemia Treatment

The US Food and Drug Administration approved the first oral treatment for anemia on February 1, specifying that daprodustat (Jesduvroq) was labeled for anemia caused by […]
January 27, 2023

FDA OKs Elacestrant for ESR1+ Advanced, Metastatic Breast Cancer FDA OKs Elacestrant for ESR1+ Advanced, Metastatic Breast Cancer

The US Food and Drug Administration approved elacestrant (Orserdu, Stemline Therapeutics, Inc) for postmenopausal women or men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer […]
January 27, 2023

FDA Approves Pirtobrutinib for R/R Mantle Cell Lymphoma FDA Approves Pirtobrutinib for R/R Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has granted accelerated approval to pirtobrutinib (Jaypirca) for relapsed or refractory mantle cell lymphoma (MCL) after at least two […]
January 26, 2023

FDA Clears Spinal Cord Stimulator for Diabetic Neuropathy FDA Clears Spinal Cord Stimulator for Diabetic Neuropathy

The US Food and Drug Administration has approved Abbott’s Proclaim XR spinal cord stimulation (SCS) system for the treatment of patients with diabetic peripheral neuropathy (DPN), […]
January 25, 2023

FDA Okays Tidepool Loop App to Help Guide Insulin Delivery FDA Okays Tidepool Loop App to Help Guide Insulin Delivery

The US Food and Drug Administration (FDA) has cleared the Tidepool Loop, a mobile application for use with compatible continuous glucose monitors (CGMs) and insulin pumps […]
January 23, 2023

FDA Approves New Type 2 Diabetes Drug Bexagliflozin FDA Approves New Type 2 Diabetes Drug Bexagliflozin

The US Food and Drug Administration (FDA) has approved bexagliflozin (Brenzavvy, TheracosBio) for the treatment of adults with type 2 diabetes. The once-daily 20-mg oral sodium-glucose […]
January 20, 2023

FDA OKs Zanubrutinib (Brukinsa) for CLL or SLL FDA OKs Zanubrutinib (Brukinsa) for CLL or SLL

The US Food and Drug Administration (FDA) granted accelerated approval for zanubrutinib (Brukinsa) to treat patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). […]
January 20, 2023

Tucatinib Plus Trastuzumab Approved for HER2+ CRC Tucatinib Plus Trastuzumab Approved for HER2+ CRC

A combination of HER2-targeted drugs used in breast cancer is now available for use in colorectal cancer. The US Food and Drug Administration (FDA) has granted […]
January 12, 2023

FDA OKs Tdap Shot in Pregnancy to Protect Newborns From Pertussis FDA OKs Tdap Shot in Pregnancy to Protect Newborns From Pertussis

The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough. The agency on Jan. 9 licensed Adacel […]
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