PipelineReview.com1d
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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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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New Data Demonstrated Best-in-Class Potential for Casdatifan, a HIF-2a Inhibitor, in Patients with Metastatic Kidney Cancer
HAYWARD, CA, USA I 15, 2025 I Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing ...
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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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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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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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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 ...
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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 ...
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FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
SILVER SPRING, MD, USA I February 14, 2025 I Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of ...
PipelineReview.com5d
FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)
SOUTH SAN FRANCISCO, CA, USA I 12, 2025 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug ...
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Novartis bolsters late-stage cardiovascular pipeline with agreement to acquire Anthos Therapeutics for USD 925 million upfront
BASEL, Switzerland I 11, 2025 I Novartis today announced that it has entered into an agreement to acquire Anthos Therapeutics, Inc., a Boston-based, ...
PipelineReview.com5d
Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer
NEW YORK, NY, USA I 13, 2025 I Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), ...