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Hereditary Angioedema News
Related terms: Quincke's disease, HAE
Donidalorsen Cuts Attack Rate in Hereditary Angioedema
MONDAY, June 3, 2024 – For patients with hereditary angioedema, donidalorsen reduces the attack rate, according to a study published online May 31 in the New England Journal of Medicine to coincide...
On-Demand Sebetralstat Speeds Symptom Relief in Hereditary Angioedema
MONDAY, June 3, 2024 – For patients with type 1 or type 2 hereditary angioedema, sebetralstat provides faster times to beginning of symptom relief than placebo, according to a study published online...
U.S. FDA Approves Takeda’s Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older
Takhzyro is the First and Only Prophylaxis Treatment Approved in the U.S. for Children 2 to
Takeda Receives U.S. FDA Approval for Prefilled Syringe Presentation of Takhzyro (lanadelumab-flyo) for Use as a Preventive Treatment for Hereditary Angioedema Attacks
CAMBRIDGE, Massachusetts, February 9, 2022– Takeda (TSE:4502/NYSE:TAK) today announced the U.S. Food and Drug Administration (FDA) approval of the Takhzyro® (lanadelumab-flyo) injection single-dose pr...
FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2020 (GLOBE NEWSWIRE) – BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved oral,...
U.S. FDA Approves Haegarda (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients (patients 6 years of age and older).
KING OF PRUSSIA, PA – September 28, 2020 – CSL Behring, a global biotherapeutics leader, announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Haeg...
FDA Approves Takhzyro (lanadelumab-flyo) for Hereditary Angioedema
August 23, 2018 – The U.S. Food and Drug Administration today approved Takhzyro (lanadelumab), the first monoclonal antibody approved in the U.S. to treat patients 12 years and older with types I...
FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema
June 22, 2017 – The U.S. Food and Drug Administration today approved Haegarda, the first C1 Esterase Inhibitor (Human) for subcutaneous (under the skin) administration to prevent Hereditary...
FDA Approves Ruconest for Hereditary Angioedema
July 17, 2014 – The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent...
FDA Approves Expanded Use of Kalbitor for the Treatment of HAE to Patients 12 Years of Age and Older
BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (NASDAQ:DYAX) today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Kalbitor (ecallantide),...
CSL Behring Receives FDA Approval of Expanded Label on Berinert for Self-administration and Treatment of Acute Laryngeal Attacks of Hereditary Angioedema
Patients with rare, sometimes life-threatening condition can now treat themselves at home at the first sign of acute facial, abdominal or laryngeal swelling attacks KING OF PRUSSIA, Pa., Jan. 3, 2012...
FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
DUBLIN, Ireland and LEXINGTON, Massachusetts, August 25, 2011 – Shire plc, the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has...
Dyax Announces FDA Approval of Kalbitor (ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema in Patients 16 Years of Age and Older
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dec 1, 2009 - Dyax Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted approval for Kalbitor (ecallantide) for the treatment of acute...
CSL Behring Announces FDA Approval of Berinert, First and Only Therapy Approved for the Treatment of Acute Abdominal and Facial Attacks of Hereditary Angioedema in U.S.
KING OF PRUSSIA, Pa., Oct. 12 /PRNewswire/ – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Berinert C1-Esterase Inhibitor, Human for...
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