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FDA Issues Draft Guidance on Expedited Programs for Regenerative Medicine
Published on Holland & Knight The FDA has released new draft guidance outlining expedited pathways for regenerative medicine therapies....
Oct 12, 2025


Next-Generation CAR T Cells Overcome Solid Tumor Barriers
Published on Technology Networks Researchers at USC Norris and City of Hope engineered CAR T cells that deliver IL-12 fused to a PD-L1...
Oct 4, 2025


Experimental Low-Cost Cancer Therapies Challenge Market Models
Published on Bloomberg A new Bloomberg feature examines how experimental low-cost cancer treatments are reshaping debates around drug...
Oct 4, 2025


AskBio Begins Phase II Gene Therapy Trial for Parkinson’s in Europe
Published on Bayer Bayer’s AskBio has randomized the first European participants in its Phase II trial of AB-1005, an investigational...
Oct 4, 2025


First Parkinson’s Patient Dosed in Pivotal Phase III Cell Therapy Trial
Published on BlueRock Therapeutics BlueRock Therapeutics has treated the first Parkinson’s disease patient in its pivotal Phase III trial...
Oct 4, 2025


Scientists Explore New Ways to Reduce Risks in Stem Cell Therapy
Published on Phys.org Researchers are developing strategies to improve the safety of stem cell therapies, focusing on reducing potential...
Oct 4, 2025


FDA Issues New Guidance on Cell, Gene, and Regenerative Therapies
Published on RAPS The US FDA has released updated guidance documents covering cell and gene therapies and regenerative medicine. These...
Oct 1, 2025


Patient-Derived Dendritic Cell Therapy Targets Hard-to-Treat Cancers
Published on The Scientist Researchers are advancing patient-derived dendritic cell immunotherapy as a personalized cancer treatment. By...
Oct 1, 2025


New Insights Into Bone Marrow Stem Cells and Immune Modulation
Published on Stem Cell Research & Therapy A recent study in Stem Cell Research & Therapy explores how bone marrow-derived stem cells...
Oct 1, 2025


First-Generation Cell and Gene Therapy Blockbusters: Zolgensma and Yescarta
Published on Alliance for Regenerative Medicine (LinkedIn) Two landmark therapies, Zolgensma and Yescarta, highlight how cell and gene...
Oct 1, 2025


FDA Approves First Oral SERD Therapy for Resistant Breast Cancer
Published on LinkedIn (via Spencer Knight) The FDA has approved Inliruqo™ (imlunestrant) from Eli Lilly, the first oral estrogen receptor...
Oct 1, 2025


Europe’s Regulatory Shake-Up Raises Concerns for Advanced Therapies
Published on Cytotherapy A new perspective warns that restructuring advanced therapy oversight within the European Medicines Agency could...
Oct 1, 2025


Stem Cells May Improve Dialysis Access for Kidney Disease Patients
Published on Mayo Clinic News Network Mayo Clinic researchers report that fat-derived mesenchymal stem cells can help prevent vein...
Oct 1, 2025


New Gene Therapy Slows Huntington’s Disease by 75%
Published on Sky News A breakthrough gene therapy called AMT-130 has slowed progression of Huntington’s disease by as much as 75% in a...
Oct 1, 2025


Lab-Grown Kidney Assembloids Show Real Function
Published on Drug Target Review USC Stem Cell scientists have created kidney assembloids that function like real organs, combining...
Sep 24, 2025


A-Gene Case Study: QbD Principles in Gene Therapy CMC
Published on Alliance for Regenerative Medicine The Alliance for Regenerative Medicine’s A-Gene initiative demonstrates how Quality by...
Sep 24, 2025


A-Cell Case Study: QbD Principles in Cell Therapy CMC
Published on Alliance for Regenerative Medicine The Alliance for Regenerative Medicine’s A-Cell initiative showcases how Quality by...
Sep 24, 2025


FDA Approves TREMFYA® for Ulcerative Colitis Induction
Published via FDA & EU regulatory updates The FDA has approved TREMFYA® as the first and only IL-23 inhibitor with both subcutaneous and...
Sep 24, 2025


Mitochondria Linked to Emerging Roles in Adult Pluripotent Stem Cells
Published in Frontiers in Bioengineering and Biotechnology A new review highlights mitochondria as central regulators of pluripotency,...
Sep 23, 2025


Pfizer to Acquire Metsera in $4.9B Deal Expanding Obesity Pipeline
Published on LinkedIn (via Spencer Knight) Pfizer announced plans to acquire Metsera for up to $4.9B, adding GLP-1 and amylin-based...
Sep 23, 2025
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