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.
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.
The U.S. FDA approved AstraZeneca Plc’s treatment for hairy cell leukemia, a slow-growing type of blood cancer.
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.
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).
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.
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.
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.
The global pharmaceuticals industry is set to win the lowest annual number of new drug approvals in 2016 since 2010.
The U.S. Senate voted overwhelmingly to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.