PipelineReview.com1d
U.S. FDA Approves Pfizer’s HYMPAVZI™ (marstacimab-hncq) for the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
NEW YORK, NY, USA I October 11, 2024 I Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ ...
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US FDA Approves Dong-A ST’s IMULDOSA™ (ustekinumab-srlf), a Biosimilar to STELARA®
Dong-A ST’s biologics license application (BLA) for Imuldosa, submitted in October 2023, is approved by the U.S. Food and Drug Administration ...
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FDA Approves Genentech’s Itovebi, a Targeted Treatment for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation
Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with ...
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Samsung Bioepis’ Fourth Quarter 2024 US Biosimilar Market Report Highlights Challenges and Strategies for Biosimilar Adoption
This year’s Q4 report newly reflects tocilizumab’s market share and Wholesale Acquisition Cost (WAC) trend analysis after biosimilars launched in Q2 Biosimilar Deep Dive section presents US biosimilar ...
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Sutro Biopharma Highlights Next-Generation ADC Innovation and Near-term Pipeline at Research Forum
Proprietary cell-free platform enables the design of next-generation ADCs intended to broaden addressable patient populations ...
PipelineReview.com3d
Pfizer’s TALZENNA® in Combination with XTANDI® Prolongs Overall Survival in Phase 3 TALAPRO-2 Trial
NEW YORK, NY, USA I October 10, 2024 I Pfizer Inc. (NYSE: PFE) today announced positive topline results from the final prespecified overall survival (OS) ...
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European Medicines Agency Confirms Acceptance of Marketing Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
October 10, 2024 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients ...
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Novo Holdings Launches Portfolio Company Booster Therapeutics to Advance New Class of Small Molecule Proteasome Activator Therapeutics
COPENHAGEN, Denmark I October 10, 2024 I Novo Holdings, a leading global life sciences investor, today announced the launch of Booster Therapeutics (Booster / the Company), a biotechnology company ...
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Vincerx Reports Positive Initial Clinical Data from Ongoing VIP943 Phase 1 Dose-Escalation Study and Provides Pipeline and Corporate Updates
VIP943 demonstrates promising safety and tolerability and achieves two complete responses to date in Phase 1 dose-escalation study, reinforcing the program’s ...
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Novavax’s Updated 2024-2025 Nuvaxovid™ COVID-19 Vaccine Receives Authorization in the EU
GAITHERSBURG, MD, USA I October 9, 2024 I Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today ...
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Scholar Rock Reports Apitegromab Meets Primary Endpoint in Phase 3 SAPPHIRE Study in Patients with Spinal Muscular Atrophy (SMA)
CAMBRIDGE, MA, USA I October 07, 2024 I Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for ...
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GSK Presents Positive Data for AREXVY, Its Respiratory Syncytial Virus (RSV) Vaccine, Indicating Protection Over Three RSV Seasons
PHILADELPHIA, PA, USA I October 08, 2024 I GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III ...