News

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 ...
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 ...
STAT13h
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 Today15h
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 ...
STAT14h
Pharmalittle: We’re reading about FDA morale, a U.S.-Swiss trade deal on pharma levies, and more
The steady erosion of experienced staff is slowly compromising FDA work and low morale is pushing more workers to the exit ...
Idaho lawmaker worked to legalize this drug. He was among the first to sell it
The drug gained a following in some circles for its supposed ability to treat COVID-19 safely, something all major medical ...
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 ...
Business Wire17h
KalVista Pharmaceuticals Announces FDA Approval of EKTERLY® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema
KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel ...