PipelineReview.com12h
Phanes Therapeutics Announces First Patient Dosed in Clinical Study of Peluntamig (PT217) in Combination with Chemotherapy
SAN DIEGO, CA, USA I February 19, 2025 I Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and ...
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Lindis Biotech and Pharmanovia Announce European Marketing Authorization Approval for Catumaxomab, A First-In-Class Treatment for Malignant Ascites
MUNICH, Germany, and BASILDON, UK I February 13, 2025 I LINDIS Biotech GmbH, a clinical stage biopharmaceutical company with a proprietary multi-specific ...
PipelineReview.com12h
Thetis Pharmaceuticals Presents New Preclinical and Clinical Data for TP-317 at ECCO 2025
Preclinical Data Highlight TP-317’s Anti-Inflammatory, Epithelial Barrier-Protective Effects ...
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Radiance Biopharma Enters Exclusive License For ROR-1 Targeted Antibody Drug Conjugate
BOSTON, MA, USA I February 19, 2025 I Radiance Biopharma, Inc., ("Radiance" or the "Company"), a biotechnology company, today announced that it has entered ...
PipelineReview.com1d
U.S. FDA Accepts Gilead’s New Drug Applications for Twice-Yearly Lenacapavir for HIV Prevention Under Priority Review
FOSTER CITY, CA, USA I February 18, 2025 I Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions ...
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FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
INCHEON, Korea I 15, 2025 I Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics ...
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Formycon announces decision on Phase III trial with FYB206 and provides update on potential need to adjust the valuation of FYB202 and FYB201
PLANEGG-MARTINSRIED I Germany I 17, 2025 I The Executive Board of Formycon AG (FSE: FYB, Prime Standard) (“Company”) has decided today to prematurely ...
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LimmaTech Vaccinates First Participants in Phase 1 Study of Staphylococcus aureus Vaccine Candidate LBT-SA7
ZURICH, Switzerland I 17, 2025 I LimmaTech Biologics AG, a clinical-stage biotech company developing vaccines for the prevention of life-threatening ...
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New Five-Year Sotyktu (deucravacitinib) Data Show Consistent Safety and Durable Response Rates in Moderate-to-Severe Plaque Psoriasis
No new safety signals observed at Year 5 in the POETYK PSO long-term extension trial, consistent with the established Sotyktu safety profile ...
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Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY
LONDON, UK I 15, 2025 I GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Penmenvy (Meningococcal ...
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Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
INCHEON, Korea I February 15, 2025 I Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for ...
PipelineReview.com5d
U.S. FDA Grants Full Approval of Deciphera’s ROMVIMZA™ (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor (TGCT)
In the MOTION Phase 3 study, ROMVIMZA met primary endpoint of improved objective response rate (ORR) compared to placebo and all key secondary endpoints with statistically significant and clinically ...