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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 ...
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Galderma’s Nemluvio® (Nemolizumab) Approved in the European Union for Moderate-to-Severe Atopic Dermatitis and Prurigo Nodularis
Nemluviois the first approved monoclonal antibody that specifically targets IL-31 receptor alpha, inhibiting the signaling of IL-31, which drives itch and is involved in inflammation and skin barrier ...
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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 ...
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European Commission Approves CSL and Arcturus Therapeutics’ KOSTAIVE®, the First Self-amplifying mRNA COVID-19 Vaccine
KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months ...
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Kexing Biopharm Obtained IND Approval for Its Self-developed GB05 from U.S. FDA
SHENZHEN, China I 14, 2025 I Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) ...
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Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer
NEW YORK, NY, USA I February 13, 2025 I Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA ® (talazoparib), an oral poly ADP-ribose polymerase (PARP) ...
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Accropeutics Announces First Patient Dosed in Phase Ib Study of RIPK2 Inhibitor AC-101
NEW YORK, NY, USA I February 13, 2025 I Accropeutics Inc. (Accropeutics), a clinical-stage biotechnology company pioneering the development of novel therapeutics that target molecular mechanisms of ...
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European Commission Approves CSL’s ANDEMBRY® (garadacimab) for the Prevention of Recurrent Attacks of Hereditary Angioedema (HAE)
– ANDEMBRY ®, the first and only once-monthly treatment targeting factor XIIa to prevent attacks in HAE patients, inhibits plasma protein factor XIIa, which initiates the cascade of events leading to ...
PipelineReview.com2d
FDA Approves Genentech’s Evrysdi Tablet as First and Only Tablet for Spinal Muscular Atrophy (SMA)
– Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution – – New tablet formulation may provide greater freedom ...
PipelineReview.com2d
U.S. FDA Approves Pfizer’s ADCETRIS® Combination Regimen for the treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NEW YORK, NY, USA I February 12, 2025 I Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ...