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Merck Receives FDA Approval of Isentress HD

Merck announced that the U.S. FDA approved Isentress HD, a new 1,200 mg once-daily dose of the company’s integrase inhibitor Isentress (raltegravir).

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Drug approvals bounce back in 2017

The number of new drugs approved for sale in United States and Europe has bounced back in 2017, suggesting a marked slowdown in 2016 was an aberration.

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FDA clears Keytruda based on cancer genetics

Merck & Co.’s Keytruda became the first cancer drug FDA-approved based on a patients’ specific genetic traits regardless of where in the body the disease originated.

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FDA to review Opdivo for HCC indication

The U.S. FDA accepted a supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma after prior sorafenib therapy.

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FDA Approves Kevzara for Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients

The U.S. FDA approved Sanofi and Regeneron Pharmaceuticals’ Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

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FDA approves first drug to specifically treat GCA

The U.S. FDA expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis.

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FDA Approves Keytruda for Bladder Cancer

Merck’s Keytruda (pembrolizumab) received FDA approval for two new indications for certain patients with locally advanced or metastatic urothelial carcinoma, including first-line treatment in patients ineligible for cisplatin-containing chemotherapy.

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FDA Approves Kalydeco for More Than 900 People Ages 2 and Older with Cystic Fibrosis Who Have Certain Residual Function Mutations

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration approved Kalydeco (ivacaftor) for use in people with cystic fibrosis ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

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FDA approves Merck combo for lung cancer

U.S. health regulators approved Merck & Co.’s Keytruda in combination with chemotherapy for previously untreated advanced lung cancer.

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Immuno-oncology drug approved for bladder cancer

U.S. health regulators granted accelerated approval for Pfizer Inc.’s immuno-oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany’s Merck KGaA.

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