Pulmonary Arterial Hypertension Drugs
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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May 27, 2025
Gilead’s TRODELVY Shows PFS Benefit in 1L Metastatic TNBC; Otsuka’s Sibeprenlimab Gets FDA Priority Review for IgA Nephropathy; Liquidia Wins FDA Nod for YUTREPIA in PAH and PH-ILD; GSK’s BLENREP Combos Get CHMP Backing in Myeloma; Relief Therapeutics Receives FDA Rare Pediatric Disease Tag for RLF-TD011
Gilead’s TRODELVY Demonstrates Significant PFS Benefit in First-Line Metastatic TNBC in ASCENT-03 Trial Gilead Sciences has announced positive topline results from the Phase III ASCENT-03 trial of TRODELVY (sacituzumab govitecan-hziy) in first-line metastatic triple-negative breast cancer (mTNBC) patients who ar...
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Jun 17, 2024
WINREVAIR Approval for Pulmonary Arterial Hypertension Treatment: Is It A Game-Changer for Merck?
Merck’s investment of $11.5 billion in acquiring Acceleron Pharma is expected to yield significant returns with the FDA’s approval of WINREVAIR (sotatercept), a pivotal component of the acquisition, for the treatment of pulmonary arterial hypertension. An estimated prevalence of pulmonary hypertension at the pop...
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Jan 28, 2020
Acceleron Pharma’s drug sotatercept touches the phase 2 mark; GT Medical receives nod for GammaTile; New treatment strategy for Parkinson’s disease
The drug, sotatercept of Acceleron Pharma, touches the phase 2 mark Acceleron Pharma, a clinical-stage biopharmaceutical company based in Boston, Massachusetts with a primary aim on the development of medicines that regulate the transforming growth factor-beta (TGF-β) superfamily of proteins that play significan...
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