Tag: Drug Approvals
Farxiga Approved to Reduce Risk for CKD Progression
SGLT2 inhibitor approved for patients with CKD to prevent kidney function decline, kidney failure, CV death, hospitalization for heart failure
FDA Approves Higher-Dose Naloxone Hydrochloride Nasal Spray
8-mg dose of naloxone hydrochloride nasal spray now approved with 2-mg and 4-mg doses
FDA Approves Immunotherapy for dMMR Endometrial Cancer
Jemperli approved for dMMR endometrial cancer that progressed after platinum-containing chemotherapy treatment
Opdivo Plus Chemotherapy Approved for Treatment of Gastric Cancer
FDA granted Opdivo first approval of immunotherapy for first-line treatment of advanced or metastatic gastric cancer
FDA Approves Therapy to Protect Bone Marrow Cells From Effects of Chemotherapy
Cosela reduces the frequency of bone marrow suppression caused by chemotherapy for extensive-stage small cell lung cancer
Combination Monoclonal Antibody Treatment Authorized for COVID-19
EUA issued for combination of bamlanivimab and etesevimab in patients with mild-to-moderate COVID-19 at high risk for disease progression
Breyanzi Approved for Certain Types of Large B-Cell Lymphoma
The CAR T cell therapy OK'd for patients who have not responded to or have relapsed after receiving two or more other systemic treatments
FDA Approves First Monthly Injectable Regimen for HIV
Trials show virologic suppression in comparable numbers of patients receiving monthly injection with Cabenuva, daily current antiretroviral regimen
Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations
Current approval of the once-daily tablet indicated for patients who have undergone complete tumor removal
Xofluza Approved for Postexposure Prevention of Flu
Influenza infection and symptoms occurred in 1 and 13 percent of those receiving Xofluza and placebo, respectively
