hereditary angioedema (HAE)
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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Jan 24, 2019
BridgeBio bags $299M; Immunochina receives $20M; Attune raises; Wren receives $23M
BridgeBio bags USD 299 Million for genetic diseases BridgeBio Pharma has received a USD299.2 million for its progress in genetic disease pipeline. This includes assets in preclinical and clinical development. Several therapeutic areas are being taken under the consideration of the pharma. Also, th...
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