FDA
Sorilux was approved for the treatment of patients age 12 and up.
The FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) as the first treatments for transthyretin-meditated amyloidosis.
The FDA extended the indication for Gattex to pediatric patients one year of age and older with short bowel syndrome.
NAYZILAM was approved to treat frequent seizure cluster episodes in epilepsy patients.
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.
“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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