Nabriva Faces Skepticism After Years Of Preparing For Novel Antibiotic Xenleta's Launch
Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.
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EU Approval Nod Possible For Novartis, Gilead/Galapagos, and Janssen
The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.
Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen
The latest drug development news and highlights from our US FDA Performance Tracker.
Medicare New Technology Add-On Payment Awards For Hospital Drugs On The Rise
Eight inpatient prescription drugs are deemed eligible for supplemental payments in 2020, a big increase from years past, based on a review of US Medicare's new technology add-on payment approvals for prescription drugs since 2011.