PipelineReview.com11h
U.S. FDA approves Celltrion’s AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA®
JERSEY CITY, NJ, USA I January 30, 2025 I Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, ...
PipelineReview.com11h
Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain
JOURNAVX is the first and only approved non-opioid oral pain signal inhibitor and the first new class of pain medicine approved in more than 20 years -- ...
PipelineReview.com11h
Gameto Announces FDA IND Clearance for Fertilo, the First iPSC-Based Therapy to Enter U.S. Phase 3 Clinical Trials
AUSTIN, TX, USA I January 30, 2025 I Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, today announced that the ...
PipelineReview.com11h
Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis
Robust evidence of the clinical benefit of WINREVAIR demonstrated in the STELLAR and ZENITH studies resulted in a loss of clinical equipoise in the HYPERION ...
PipelineReview.com11h
Ethris Presents Positive Topline Phase 1 Data with mRNA Lead Candidate ETH47 for Uncontrolled Asthma
MUNICH, Germany I January 30, 2025 I Ethris GmbH, a leading biotechnology company pioneering next-generation RNA therapeutics and vaccines, today announced ...
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Tubulis Announces First Patient Dosed in Phase I/IIa Trial Evaluating ADC TUB-030 in Advanced Solid Tumors
MUNICH, Germany I January 30, 2025 I Tubulis announced today that its second drug candidate, TUB-030, has entered clinical evaluation with successful dosing ...
PipelineReview.com2d
Vincerx Pharma, Inc. and Oqory, Inc. Highlight Promising Data for Oqory’s TROP2 Antibody Drug Conjugate, OQY-3258
SAN MATEO, CA, USA I January 29, 2025 I Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting ...
PipelineReview.com3d
Kashiv Biosciences Announces Successful Phase 1 Results for Abatacept Biosimilar Candidate, KSHB002
PISCATAWAY, NJ, USA I January 28, 2025 I Kashiv Biosciences, LLC, a global leader in biopharmaceutical innovation, today announced that their abatacept biosimilar candidate, KSHB002, has successfully ...
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miRecule and GBI Biomanufacturing Announce Strategic Partnership to Advance Development of Antibody RNA Conjugate (ARC) Therapies
PLANTATION, FL, and GAITHERSBURG, MD, USA I January 28, 2025 I miRecule, a biotechnology company pioneering RNA therapies, and GBI Biomanufacturing, a leading contract development and manufacturing ...
PipelineReview.com3d
Helicore Biopharma Emerges from Stealth to Continue Advancing Portfolio of First-in-Class GIP Antagonists for Obesity and Related Conditions
SOUTH SAN FRANCISCO, CA, USA I January 28, 2025 I Helicore Biopharma Inc., a biopharmaceutical company focused on the discovery and development of first-in-class glucose-dependent insulinotropic ...
PipelineReview.com3d
Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases
SOUTH SAN FRANCISCO, CA, USA I January 28, 2025 I Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T ™) ...