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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 Once-a-Month HIV Therapy

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

Regulators Discuss Approval of New Alzheimer Disease Drug

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

Regulators Discuss Approval of New Alzheimer Disease Drug

Xofluza Approved for Postexposure Prevention of Flu

Influenza infection and symptoms occurred in 1 and 13 percent of those receiving Xofluza and placebo, respectively

Panel Recommends Against Approval of Experimental Drug for Alzheimer Disease

First Drug Approved to Treat Rare Metabolic Disorder

Oxlumo granted approval to treat primary hyperoxaluria type 1

The U.S. approval and regulation processes for pharmaceutical agents have evolved during the last four decades

Evolution of Approval, Regulation Processes for Drugs Explored

FDA drug review times down from 1983 to 2017, but time from clinical testing to approval did not change
A new drug to treat early Alzheimer disease will be submitted to the U.S. Food and Drug Administration for approval

New Alzheimer Disease Drug to Be Submitted for FDA Approval

New analysis of study results suggests highest dose of aducanumab may help slow cognitive decline