News

After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...
US FDA approves KalVista's oral swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
US FDA approves KalVista Pharma's swelling disorder drug, shares rise
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral ...
STAT8h
Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
ALS News Today9h
FDA grants orphan drug status to ALS gene therapy SNUG01
The FDA granted orphan drug designation to Sineugene Therapeutics' SNUG01, a first-in-class experimental gene therapy for ...
US FDA approves KalVista Pharma's swelling disorder drug
KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug for a type of hereditary swelling disorder, sending its shares up 33.3% in premarket trading.
Mustang Bio Granted Orphan Drug Designation by U.S. FDA for MB-101 (IL13Ra2-targeted CAR T-cells) to Treat Astrocytomas and Glioblastoma
In an ongoing Phase 1 trial published in Nature Medicine, MB-101 was well-tolerated and 50% of patients achieved stable ...
Mustang Bio Shares Jump After Orphan Drug Designation for Cancer Treatment
Mustang Bio shares more than quadrupled, to $5.23, after the company on Monday said the Food and Drug Administration granted orphan drug designation to Mustang for MB-101 for the treatment of ...
'Gas station heroin': The drug sold as a dietary supplement that's linked to overdoses and deaths
The US Food and Drug Administration (FDA) has issued an urgent warning about tianeptine—a substance marketed as a dietary ...