PipelineReview.com11h
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 ...
PipelineReview.com1d
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.com1d
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 ...
PipelineReview.com1d
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 ...
PipelineReview.com1d
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) ...
PipelineReview.com2d
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), ...
PipelineReview.com2d
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 ...
PipelineReview.com2d
Accropeutics Announces First Patient Dosed in Phase Ib Study of RIPK2 Inhibitor AC-101
NEW YORK, NY, USA I 13, 2025 I Accropeutics Inc. (Accropeutics), a clinical-stage biotechnology company pioneering the development of novel ...
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 12, 2025 I Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental ...
PipelineReview.com2d
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.com2d
Restore Vision Announces First Patient Dosed in Phase I/II Clinical Trial of RV-001 for Gene-Agnostic Retinitis Pigmentosa
TOKYO, Japan I 13, 2025 I Restore Vision Inc., a clinical-stage biotechnology company advancing gene therapies for retinal disorders, today announced ...
PipelineReview.com2d
Update on extraintestinal pathogenic E. coli vaccine phase 3 clinical study
PARIS, France I 13, 2025 I A scheduled review of the E.mbrace phase 3 study (clinical trial identifier: NCT04899336) conducted by an independent data ...