Hereditary Angioedema
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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Dec 18, 2023
The Expanding Market of Complement Inhibitors
The development of complement inhibitors has been growing rapidly over the years, and it has proved to be one of the breakthroughs in various therapeutic areas. These inhibitors act on the dysregulated complement system, a group of proteins that forms an essential part of innate immunity. This system comes into eff...
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Jan 08, 2018
Hereditary Angioedema (HAE) – Active drug pipeline
Hereditary Angioedema (HAE) is an autosomal dominant disease which is caused by a deficiency in functional C1 inhibitor. It is a rare hereditary disease which is characterized by painful, unpredictable, recurrent attacks of inflammation and swelling affecting the hands, feet, face, abdomen, urogenital tract, and the...
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Apr 18, 2017
Novartis gets CAR-T drug; Shire aims to block; Xeljanz stands; Payer snubs; Lawmakers pass a bill
Novartis gets second CAR-T candidate FDA ‘breakthrough’ tag As the battle between Swiss major Novartis and biotech rival Kite Pharma heats up to be the first to market a CAR-T cancer med, the Big Pharma has been handed its second FDA ‘breakthrough’ tag for its eagerly awaited JULIET trial. This latest label, which c...
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