The company announced that the agency approved Pharming’s leniolisib, now to be marketed as Joenja, for the treatment of the ultra-rare disease-activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).
Tag Archive for: orphan drug
After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.
The regulator, known as CNMC, said the pharmaceutical company had abused its dominant position as holder of the only medicine available in Spain against the rare genetic disease Cerebrotendinous Xanthomatosis.
Eton Pharmaceuticals, Inc has sold its hospital products to Dr. Reddy’s Laboratories SA, a subsidiary of Dr. Reddy’s Laboratories, Ltd. for total payments of up to $50 million.
