Food and Drug Administration (FDA)
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NAYZILAM was approved to treat frequent seizure cluster episodes in epilepsy patients.
Project Facilitate is a pilot project to create a single point of contact for the FDA’s oncology expanded access requests.
Pfizer’s Fragmin was approved to reduce the recurrence of VTE in patients one month of age or older.
The combination of Venclexta and Gazyva was rapidly approved by the FDA under a pilot program.
The approval marks the first time the FDA has approved a checkpoint inhibitor for the treatment of advanced renal cell cancer.
The panel opposed approval of Daiichi Sankyo’s AML drug but supported approval for its TGCT treatment.
In its first-quarter financial report, Solid Biosciences updated on its Phase I/II IGNITE DMD clinical trial. The progress was marred by adverse events.
“With today’s FDA approval, Eylea has once again set a high bar for the treatment of diabetic eye diseases,” stated George D. Yancopoulos, president and chief scientific officer at Regeneron.
The drug was approved as a second-line treatment for HCC patients who have an alpha-fetoprotein biomarker.
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