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 ...
PipelineReview.com1d
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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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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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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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 ...
PipelineReview.com1d
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.com7d
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, ...
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Evolus Announces FDA Approval of Evolysse™ Form and Evolysse™ Smooth Injectable Hyaluronic Acid Gels
First Major Technological Breakthrough in Hyaluronic Acid Dermal Fillers in a Decade; U.S. Launch Planned in Q2 2025 ...
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 ...
PipelineReview.com3d
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 ...
PipelineReview.com3d
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
Merilog is the third insulin biosimilar product approved by the FDA and joins the two long-acting insulin biosimilar products approved in 2021 by the FDA. Approval of biosimilar products can increase ...