News from the FDA/CDC
News from the FDA/CDC
FDA OKs sacituzumab govitecan for HR+ metastatic breast cancer
Label expansion for the Trop-2–directed antibody-drug conjugate was based on the TROPICS-02 trial.
News from the FDA/CDC
FDA approves futibatinib (Lytgobi) for certain biliary tract cancers
Futibatinib is “a key example of the potential of precision medicine” in intrahepatic cholangiocarcinoma.
News from the FDA/CDC
FDA OKs sodium thiosulfate injection to reduce ototoxicity risk in children with cancer
“Historically, there have been no approved treatments for preventing cisplatin-induced hearing loss.”
News from the FDA/CDC
Intera Oncology recalls hepatic artery infusion pumps for possible life-threatening issue
The recall follows reports from clinicians that the pumps, which are implanted to deliver chemotherapy to treat liver tumors, were delivering...
News from the FDA/CDC
COVID to blame as U.S. life expectancy falls
The overall drop took national life expectancy from 78.8 years in 2019 to 77 years in 2020.
News from the FDA/CDC
FDA approves first gene therapy, betibeglogene autotemcel (Zynteglo), for beta-thalassemia
The one-time gene therapy represents a potential cure in which functional copies of the mutated gene are inserted into patients’ hematopoietic...
News from the FDA/CDC
FDA approves Enhertu (trastuzumab deruxtecan) for HER2 lung cancer
“These results establish the new standard of care for patients with NSCLC harboring HER2 mutations.”
News from the FDA/CDC
Long COVID doubles risk of some serious outcomes in children, teens
“Many of these conditions were rare or uncommon among children in this analysis, but even a small increase in these conditions is notable.”
News from the FDA/CDC
FDA grants emergency authorization for Novavax COVID vaccine
Clinical trials found the vaccine to be 90.4% effective in preventing mild, moderate or severe COVID-19.
News from the FDA/CDC
FDA warns of increased risk of death with CLL, lymphoma drug
“The trial also found Copiktra was associated with a higher risk of serious side effects ...”
News from the FDA/CDC
FDA withdraws lymphoma drug approval after investigation
Last February, the FDA said it was investigating a possible increased risk of death associated with umbralisib. Five months later, the results are...