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FDA Approves Paratek’s Oral Antibiotic Nuzyra

The U.S. FDA approved Paratek Pharmaceuticals Inc.’s Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections.

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Sun Pharma’s Xelprost Wins FDA Approval

The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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FDA approves AstraZeneca’s drug for rare form of blood cancer

The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.

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FDA approves Shire drug for rare swelling disorder

The U.S. FDA approved a first-of-its-kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling.

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2-Drug HIV Treatment Filed for U.S., EU Approval

ViiV Healthcare made regulatory submissions to the EMA and the U.S. FDA for a single-tablet, two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen).

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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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2017 Annual Report: Top 10 Pipelines

There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.

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New drug approvals fall to six-year low in 2016

2016 turned out to be a disappointing one for new drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015’s tally of 45.

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New drug approvals dive in 2016

The global pharmaceuticals industry is set to win the lowest annual number of new drug approvals in 2016 since 2010.

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Congress passes sweeping new health bill

The U.S. Senate voted overwhelmingly to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.

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