Tag: Drug Approvals
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
First Drug Approved to Treat Rare Metabolic Disorder
Oxlumo granted approval to treat primary hyperoxaluria type 1
Evolution of Approval, Regulation Processes for Drugs Explored
