FDA Office of New Drugs

FDA Office of New Drugs
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FDA Office of New Drugs

 •  February 16

Release The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first...

FDA Office of New Drugs

 •  February 15

Statement Seasonal flu has been widespread this year, impacting millions of people across the country. It has been an especially challenging season, with high rates of hospitalization for both influenza and its complications, which include pneumonia and the exacerbation of chronic conditions such as asthma and congestive heart failure. Many schools...

FDA Office of New Drugs

 •  February 15

Summary FDA expands treatment window for use of clot retrieval devices in certain stroke patients Release The U.S. Food and Drug Administration today cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients. This device is...

FDA Office of New Drugs

 •  February 15

Statement New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago. Perhaps one of the most significant developments is the advent of new gene therapies and drugs that boost the immune system’s ability to target tumor cells. But we recognize that progress across different therapeutic areas...

FDA Office of New Drugs

 •  February 14

Release The U.S. Food and Drug Administration today approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant...

FDA Office of New Drugs

 •  February 13

Summary Additional resources will help advance initiatives to support novel medical technology and public health priorities such as generic drug development, pharmacy outsourcing and novel domestic manufacturing capabilities Statement New scientific opportunities, as well as advances in manufacturing and commerce, give the U.S. Food and Drug...

FDA Office of New Drugs

 •  February 6

Summary FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties. Statement Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound...

FDA Office of New Drugs

 •  February 1

Statement As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals,...

FDA Office of New Drugs

 •  January 30

Statement The issue of opioid misuse and abuse remains one of my highest priorities and we believe it’s going to take carefully developed, sustained, and coordinated action by everyone involved to reduce the tide of opioid addiction and death afflicting our communities; while maintaining appropriate prescribing for patients in medical need. We...

FDA Office of New Drugs

 •  January 24

Summary FDA and FTC take action against companies illegally marketing unapproved products with claims to help with opioid addiction and withdrawal Release The U.S. Food and Drug Administration and the Federal Trade Commission today posted joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally...