PipelineReview.com11h
Datopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn
TOKYO, Japan & MUNICH, Germany I4, 2024 I Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the ...
PipelineReview.com1d
RAPT Therapeutics and Shanghai Jemincare Pharmaceutical Announce Exclusive License Agreement for Novel Long-Acting anti-IgE Antibody
Jemincare receives $35 million upfront payment, up to $672.5 million in milestone payments and high single-digit to low-double digit royalties on future sales – – Jemincare is currently conducting ...
PipelineReview.com1d
FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
MD, USA I3, 2024 I Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide ...
PipelineReview.com1d
Zura Bio Launches Global Phase 2 TibuSURE Study to Evaluate Tibulizumab in Adults With Systemic Sclerosis
HENDERSON, NV, USA I3, 2024 I Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel ...
PipelineReview.com1d
Ikena Oncology and Inmagene Biopharmaceuticals Announce Agreement for Merger and Private Placement
Inmagene Biopharmaceuticals is a clinical stage company focused on developing IMG-007, a non-depleting anti-OX40 monoclonal antibody with an extended half-life and a silenced ADCC function The ...
PipelineReview.com1d
Keymed Biosciences Announces Approval Of Stapokibart For The Treatment Of Chronic Rhinosinusitis With Nasal Polyposis
CHENGDU, China I December 23, 2024 I Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the “NMPA”) of China has recently approved the supplemental New ...
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Wave Life Sciences Announces Submission of First Clinical Trial Application for WVE-007 (siRNA Targeting INHBE) in Obesity
WVE-007 is a novel approach for treating obesity and is designed to silence INHBE to achieve healthy, sustainable weight loss through fat burning, muscle ...
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Tagrisso approved in the EU for patients with unresectable EGFR-mutated lung cancer
Approval based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years In the trial, Tagrisso reduced the risk of disease progression ...
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CStone Announces Submission of Clinical Trial Application in Australia for CS2009, an Innovative PD-1/VEGF/CTLA-4 Trispecific Antibody
SHANGHAI, China I December 22, 2024 I CStone Pharmaceuticals (“CStone”, HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, ...
PipelineReview.com3d
U.S. FDA Approves Pfizer’s BRAFTOVI® Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer
NEW YORK, NY, USA I December 20, 2024 I Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) in combination with cetuximab ...
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Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma
DURHAM, NC, USA I December 19, 2024 I Humacyte, Inc. (Nasdaq: HUMA), a biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today ...
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Vertex Announces US FDA Approval of ALYFTREK™,a Once-Daily Next-in-Class CFTR Modulator for the Treatment of Cystic Fibrosis
– ALYFTREK ™ is approved for patients 6 years and older with at least one responsive mutation, including 31 additional mutations not responsive to other CFTR modulator therapies – – In head-to-head ...