Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
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Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases
Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.
Keeping Track: J&J Submits Ponesimod NDA For MS; US FDA Clears Epclusa For Pediatric HCV
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.