The FDA has approved garadacimab-gxii for prophylactic use in patients aged 12 years and older with hereditary angioedema, ...

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present new findings from patient-focused ...

H2 2025 catalysts to watch, biopharma implications of President Trump’s tax law, KalVista’s new hereditary angioedema drug that Marty Makary reportedly tried to reject, another lawsuit aimed at Health ...

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.

Moderna (MRNA), an undervalued name in the biotech space, rose to prominence during the COVID-19 pandemic. This occurred when ...

Ekterly becomes the first FDA-approved oral on-demand treatment for hereditary angioedema in patients aged 12 years and older ...

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 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 ...