Monthly Prescribing Reference

Cinryze Approved for Pediatric Patients With Hereditary Angioedema

The approval was based on data from a randomized, single-blind, multicenter, dose-ranging, crossover study which evaluated the safety and efficacy of Cinryze in 12 pediatric patients (7 to 11 years ...
Monthly Prescribing Reference

Berotralstat Gets Priority Review for Pediatric Hereditary Angioedema

If approved, berotralstat would be the first oral prophylactic HAE therapy for children under the age of 12. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug ...

KalVista Pharmaceuticals Announces Inclusion of EKTERLY® (sebetralstat) as a First-Line Therapy for Adolescents 12 and Older in International Pediatric HAE Guideline

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the newly published International Guideline on the ...

BioCryst’s First Profitable Year Recasts Hereditary Angioedema Growth Story

BioCryst Pharmaceuticals (NasdaqGS:BCRX) reported its first full year of profitability, supported by commercial traction for ...
Healio

Childhood hereditary angioedema worries, interrupts lives of patients, caregivers

Please provide your email address to receive an email when new articles are posted on . Researchers surveyed/interviewed children and their caregivers, adolescents and health care professionals (HCP).
Nasdaq

HAEGARDA is the first and only subcutaneous prophylactic HAE treatment approved for children 6 years of age and older

KING OF PRUSSIA, Pa., Sept. 28, 2020 /PRNewswire/ -- CSL Behring, a global biotherapeutics leader, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication ...
Healio

FDA grants priority review to lanadelumab-flyo for pediatric hereditary angioedema attacks

Please provide your email address to receive an email when new articles are posted on . The FDA has granted priority review to a supplemental biologics license application for the potential expanded ...
Business Wire

KalVista Announces FDA Acceptance of New Drug Application for Sebetralstat for Oral On-Demand Treatment of Hereditary Angioedema

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug ...
Seeking Alpha

BioCryst Begins Enrollment in Pivotal APeX-P Trial Evaluating ORLADEYO® (berotralstat) in Pediatric Patients with Hereditary Angioedema

RESEARCH TRIANGLE PARK, N.C., Jan. 26, 2023 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (BCRX) (Nasdaq: BCRX) today announced the enrollment of the first patient in the pivotal APeX-P trial ...