After delaying a June PDUFA date, the U.S. FDA has approved Kalvista Pharmaceuticals Inc.’s Ekterly (sebetralstat) for hereditary angioedema (HAE) in those aged 12 and older. The plasma kallikrein ...

Ekterly comes in the form of a 300 mg tablet. The recommended dosage is 600 mg split into two doses taken at the earliest sign of an attack, according to the prescribing information. Additional ...

The Food and Drug Administration (FDA) has approved Ekterly ® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an ...

For the second time in under 3 weeks, the FDA has approved treatment for the inherited genetic disorder characterized by ...

Ekterly’s road to approval was not a smooth one. Last month, the FDA informed KalVista it would not meet its PDUFA date due ...

Poly(ethylene glycol) (PEG) is used in many common products, such as cosmetics. PEG, however, is also used to covalently conjugate drug molecules, proteins, or nanocarriers, which is termed PEGylation ...

Angioedema Treatment Global Market Report 2025. The Business Research Company's Angioedema Treatment Global Market Report 2025 – Market Size, Trends, And ...

Primary treatment for any ADR is immediate discontinuation of the drug after prompt recognition, especially in the case of angioedema. [2, 8, 9, 10] Secondary treatment of angioedema includes ...

FRIDAY, June 20, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Andembry (garadacimab-gxii) as the only treatment targeting factor XIIa for prophylactic use to prevent ...