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FDA Accepts Kowa’s K-911 Glaucoma Drug Application for Review

Aug 31, 2026
The U.S. Food and Drug Administration (FDA) has accepted Kowa Pharmaceuticals America’s New Drug Application (NDA) for K-911, an investigational eye drop being developed to reduce…
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AusperBio Raises $120 Million to Advance Hepatitis B Drug

Aug 31, 2026
AusperBio Therapeutics has raised $120 million in a Series C financing round to support the development of its experimental treatments for chronic hepatitis B (CHB) and prepare its lead…
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FDA Approves LISRAYA for Adults With Dermatomyositis

Aug 31, 2026
The U.S. Food and Drug Administration (FDA) has approved Priovant Therapeutics’ LISRAYA (brepocitinib) 30 mg for the treatment of adults with dermatomyositis (DM), a rare autoimmune…
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FDA Approves Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes

Aug 31, 2026
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Mounjaro (tirzepatide) to reduce the risk of major cardiovascular events in adults with type 2 diabetes who are at…
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Teva to Bid for BioXcel Assets in Chapter 11 Sale

Aug 31, 2026
BioXcel Therapeutics has entered into an agreement with Teva Pharmaceuticals International GmbH for the sale of substantially all of its assets as the biotechnology company begins…
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FDA Approves Tivicay PD for Infants With HIV

Aug 27, 2026
The U.S. Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir) for the treatment of HIV-1 infection in children weighing at least 2 kg. The…
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FDA Grants Rare Pediatric Disease Designation to ReviR’s RTX-117

Aug 27, 2026
The U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to ReviR Therapeutics’ investigational drug RTX-117 for the treatment of…
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FDA Approves Ziihera Combinations for HER2-Positive GEA

Aug 27, 2026
The U.S. Food and Drug Administration (FDA) has approved two Ziihera (zanidatamab-hrii)-based treatment regimens for the first-line treatment of adults with unresectable locally…
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FDA Approves RASONQUE for Metastatic Pancreatic Cancer

Aug 27, 2026
The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ RASONQUE (daraxonrasib), a once-daily oral treatment for adults with metastatic pancreatic adenocarcinoma…
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REGENXBIO Delays RGX-121 Filing After Spine MRI Findings

Aug 25, 2026
REGENXBIO has provided an update on RGX-121, its investigational gene therapy for Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome. The company said it does not…
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Industry Reports

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Press Releases

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