PipelineReview.com6h
Formycon and Fresenius Kabi receive European Commission approval for FYB202/Otulfi® (ustekinumab) for the treatment of serious inflammatory diseases
PLANEGG-MARTINSRIED, Germany I September 27, 2024 I Formycon AG (FSE: FYB, “Formycon”) and its commercialization partner Fresenius Kabi jointly announce that ...
PipelineReview.com4h
BlueRock Therapeutics’ Investigational Cell Therapy Bemdaneprocel for Parkinson’s Disease Shows Positive Data at 24-Months
BERLIN, Germany & CAMBRIDGE, MA, USA I September 27, 2024 I Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG ...
PipelineReview.com6h
Dupixent approved in the US as the first-ever biologic medicine for patients with COPD
PARIS, France and TARRYTOWN, NY, USA I7, 2024 I The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on ...
PipelineReview.com10h
Minovia Therapeutics Announces FDA Clearance of IND Application for a Phase Ib Clinical Trial of MNV-201 in Low Risk Myelodysplastic Syndrome
MNV-201 is a mitochondrial cell therapy product composed of autologous hematopoietic stem cells enriched with allogeneic mitochondria ...
PipelineReview.com1d
AbbVie Announces Positive Topline Results from Phase 3 TEMPO-1 Trial Evaluating Tavapadon as a Monotherapy for Parkinson’s Disease
NORTH CHICAGO, IL, USA I6, 2024 I AbbVie (NYSE: ABBV) today announced positive topline results from its pivotal Phase 3 TEMPO-1 trial for ...
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Repair Biotechnologies and Genevant Sciences to Collaborate to Develop mRNA-LNP Therapy with First-in-Class Potential to Turn Back Atherosclerosis
SYRACUSE, NY, USA; VANCOUVER, Canada; and BASEL, Switzerland I6, 2024 I Repair Biotechnologies, a biotechnology company developing first-in-class ...
PipelineReview.com1d
ReCode Therapeutics Doses First Patient in Phase 1b Clinical Study of RCT2100 for the Treatment of Cystic Fibrosis
Phase 1b study will evaluate the safety and tolerability of multiple ascending doses of RCT2100 in people with cystic fibrosis – ...
PipelineReview.com1d
Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis
SAN FRANCISCO, CA, USA and SUZHOU, China I September 26, 2024 I Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical ...
PipelineReview.com1d
Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer
Based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival by more than three years ...
PipelineReview.com1d
Positive Phase III Results for Genentech’s Gazyva Show Superiority to Standard Therapy Alone in People With Lupus Nephritis
The REGENCY study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus ...
PipelineReview.com1d
PolTREG starts preclinical CAR-Treg development for neuroinflammatory autoimmune diseases
GDANSK, Poland I6, 2024 I PolTREG S.A. (Warsaw Stock Exchange: PTG), a clinical-stage biotechnology company developing cellular therapies for a ...
PipelineReview.com1d
Pfizer Voluntarily Withdraws All Lots of Sickle Cell Disease Treatment OXBRYTA® (voxelotor) From Worldwide Markets
NEW YORK, NY, USA I September 25, 2024 I Pfizer Inc. (NYSE: PFE) announced today that it is voluntarily withdrawing all lots of OXBRYTA ® (voxelotor) for the treatment of sickle cell disease (SCD) at ...