Food and Drug Administration (FDA)

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U.S. FDA Approves NEXAVAR® (sorafenib) for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment

22 November 2013 | By Amgen

First and only FDA-approved treatment option for patients with this type of thyroid cancer...

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New Drug Application for naloxegol accepted by United States Food and Drug Administration

19 November 2013 | By AstraZeneca

The NDA filing was based on comprehensive data from the core Phase III KODIAC programme...

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IMBRUVICA™ (ibrutinib) capsules now approved in the U.S. for Mantle Cell Lymphoma patients who have received at least one prior therapy

13 November 2013 | By Johnson & Johnson

Janssen Biotech, Inc. [“Janssen”] today announced the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA™ (ibrutinib) capsules for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.1 This indication is based on overall response rate (ORR). An improvement in survival or…

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Micardis crosses 50 million patient-years of experience on 15th anniversary

11 November 2013 | By Boehringer Ingelheim

Boehringer Ingelheim announces clinical experience with its angiotensin II receptor blocker (ARB) has reached 50 million patient-years of real world experience...

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Johnson & Johnson and its Subsidiaries conclude previously disclosed settlement agreements with U.S. Department of Justice and 45 States

4 November 2013 | By Johnson & Johnson

The resolution includes total settlement amounts of approximately $2 billion to the federal government...

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Simeprevir administered once daily as part of combination therapy demonstrates sustained virologic response in treatment-naïve and treatment-experienced genotype 1 chronic hepatitis C adult patients

2 November 2013 | By Janssen R&D Ireland

“The breadth of simeprevir data presented at AASLD reinforce its potential as a treatment option..."

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Abbott’s MitraClip® treatment demonstrates positive results for patients with degenerative mitral regurgitation at prohibitive risk for surgery

30 October 2013 | By Abbott

The MitraClip device provides physicians with a breakthrough treatment option for patients suffering from MR...

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New two-year results show SIMPONI® ARIA™ (GOLIMUMAB) for infusion inhibited radiographic progression in patients with active rheumatoid arthritis

28 October 2013 | By Johnson & Johnson

Nearly 70 percent of patients receiving SIMPONI ARIA at two years demonstrated ACR 20 response...

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Abbott’s first-in-class MitraClip® device now available for U.S. patients

25 October 2013 | By Abbott

"With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option..."

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GSK’s drisapersen to receive FDA breakthrough therapy designation for potential treatment of patients with DMD

27 June 2013 | By GlaxoSmithKline

GlaxoSmithKline has received a verbal notification...

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Novartis drug Ilaris® approved by FDA

10 May 2013 | By Novartis

Novartis announced that the US Food and Drug Administration (FDA) has approved Ilaris® (canakinumab)...

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Gilead submits New Drug Application to U.S. FDA for Sofosbuvir

8 April 2013 | By Gilead Sciences

Sofosbuvir, a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus infection...

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FDA perspective published in the New England Journal of Medicine reinforces safety of Pradaxa® (dabigatran etexilate)

26 March 2013 | By Boehringer Ingelheim

A new perspective from the U.S. FDA...

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FDA accepts Biogen Idec’s Biologics License Application for first long-lasting factor IX therapy for hemophilia B

4 March 2013 | By Biogen Idec

“We are encouraged by the FDA’s acceptance of our application..."

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Sanofi New Drug Application for Lixisenatide accepted for review by FDA

19 February 2013 | By Sanofi

Sanofi announced that the U.S. FDA has accepted for review a New Drug Application for lixisenatide...