PipelineReview.com17h
European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab)
November 04, 2024 I Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients ...
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HuidaGene Therapeutics Receives the First-Ever FDA Clearance of CRISPR/Cas13 RNA-Editing HG202 for Macular Degeneration
SHANGHAI, China and CLINTON, NJ, USA I 4, 2024 I HuidaGene Therapeutics ("HuidaGene"), a global clinical-stage biotechnology company, announced that ...
PipelineReview.com15h
Surrozen and TCGFB, Inc. Announce Strategic Research Collaboration to Develop TGF-β Antibodies for Idiopathic Pulmonary Fibrosis
Research collaboration to leverage Surrozen’s antibody research capabilities and expertise to discover a potential first in class treatment for patients with Idiopathic Pulmonary Fibrosis SOUTH SAN ...
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Korro Announces Regulatory Filing for Initiation of KRRO-110 First-In-Human Study and Formation of Clinical Advisory Board
-Interim readout expected in second half of 2025 and completion of Phase 1/2 study anticipated in 2026 CAMBRIDGE, MA, USA I November 04, 2024 I Korro Bio, Inc. (Korro) (Nasdaq: KRRO), a ...
PipelineReview.com1d
Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024
After 28 Days of Dosing with Oral Tablet of VK2735 Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild GI-Related Adverse Event Profile Updated Results from VENTURE Phase 2 ...
PipelineReview.com1d
Xencor Doses First Subject in Phase 1/2 Study of XmAb®942 in Development for Patients with Inflammatory Bowel Disease
PASADENA, CA, USA I November 04, 2024 I Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the ...
PipelineReview.com1d
Cytoki Pharma Announces First Patient Dosed in Phase 2 Study of CK-0045 in Obesity and Type 2 Diabetes
The Phase 2 study will evaluate the efficacy, safety and tolerability of the company’s lead lipidated IL-22 analogue, CK-0045, in patients with obesity and type 2 diabetes COPENHAGEN, Denmark I ...
PipelineReview.com1d
Ionis announces FDA acceptance of New Drug Application for donidalorsen for prophylactic treatment of HAE
CARLSBAD, CA, USA I 4, 2024 I Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has ...
PipelineReview.com2d
Sutro Biopharma Announces Initiation of the Registration-enabling REFRαME-P1 Trial with Luvelta for Pediatric Patients with CBF/GLIS AML
SOUTH SAN FRANCISCO, CA, USA I 01, 2024 I Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering ...
PipelineReview.com8d
Vaxxas Licenses Next-Generation Vaccine for Respiratory Syncytial Virus (RSV) from the United States National Institutes of Health (NIH)
BRISBANE, Australia & CAMBRIDGE, MA, USA I8, 2024 I Vaxxas, a clinical-stage biotechnology company commercializing a novel ...
PipelineReview.com5d
Three Phase 3 Trials of Datopotamab Deruxtecan-Based Combinations Initiated in Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer
TOKYO, Japan & BASKING RIDGE, NJ, USA I October 30, 2024 I The first patients have been dosed in three global, randomized phase 3 trials evaluating the ...