Hereditary Angioedema Market
Jan 30, 2026
DAWNZERA’s EU Approval Strengthens the Hereditary Angioedema Treatment Landscape
Summary The European Commission granted marketing authorization for DAWNZERA (donidalorsen) on January 21, 2026. Developed by Ionis Pharmaceuticals and Otsuka Pharmaceutical, it is the first and only RNA-targeted therapy approved in the EU for the prevention of hereditary angioedema (HAE). Approval ...
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Jul 14, 2025
KalVista’s EKTERLY: First-Ever Oral Hereditary Angioedema Treatment
Following an unexpected regulatory delay last month, KalVista Pharmaceuticals has officially entered the commercial market with the FDA approval of its plasma kallikrein inhibitor, sebetralstat. On July 7, 2025, the FDA cleared sebetralstat, now branded as EKTERLY, as an oral treatment for acute hereditary angioede...
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Jul 08, 2025
Merck’s WINREVAIR Granted FDA Priority Review for Pulmonary Arterial Hypertension; KalVista’s EKTERLY Approved by FDA as First Oral On-Demand Therapy for Hereditary Angioedema; Fujifilm’s FF-10832 Receives FDA Orphan Drug Designation for Biliary Tract Cancer; Mustang Bio’s MB-101 Granted FDA Orphan Drug Designation for Glioblastoma and Astrocytomas; Denali’s Tividenofusp Alfa Accepted for FDA Priority Review for Hunter Syndrome
Merck's WINREVAIR Gets FDA Priority Review for Pulmonary Arterial Hypertension Merck, also known as MSD outside the U.S. and Canada, announced that the FDA has accepted and granted Priority Review to the supplemental Biologics License Application (sBLA) for WINREVAIR (sotatercept-csrk). The application seeks to ...
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Jun 17, 2025
Celltrion Announces FDA Nod for New STEQEYMA Presentation to Broaden Pediatric Use; CSL’s ANDEMBRY Gets FDA Nod as First Factor XIIa Inhibitor for Hereditary Angioedema; Ocugen’s OCU410ST Cleared by FDA to Begin Phase II/III Trial in Stargardt Disease; Milestone Pharmaceuticals Submits FDA Response for CARDAMYST in PSVT; AbbVie’s MAVYRET Approved by FDA as First and Only Therapy for Acute Hepatitis C
Celltrion Announces FDA Approval of New STEQEYMA Presentation, Expanding Pediatric Dosing Options Celltrion, Inc. has announced that the FDA has approved an additional presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, in a 45mg/0.5mL single-dose vial for subcutaneous injection. This new formu...
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Mar 06, 2024
Major Highlights and Insights from the AAAAI Annual Meeting, 2024
American Academy of Allergy, Asthma & Immunology (AAAAI) 2024 annual meeting, is the premier educational event for allergists/immunologists around the world that was held from February 23 to 26 at the Walter E. Washington Convention Center this year. The American Academy of Allergy, Asthma & Immunology (AAA...
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