HUTCHMED’s Fanregratinib NDA for Intrahepatic Cholangiocarcinoma Accepted for Priority Review in China

NDA supported by results from a Phase II registration trial in China — — Second most common form of liver cancer after hepatocellular ...

December 31, 2025 | Wednesday | News
CARsgen Submits Dual IND Applications in China for Allogeneic BCMA CAR-T CT0596 in Multiple Myeloma and Plasma Cell Leukemia

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that it has submi...

December 30, 2025 | Tuesday | News
T-MAXIMUM Pharmaceutical Secures FDA IND Clearance for Allogeneic CAR-T MT027 in Recurrent Glioblastoma

T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food an...

December 29, 2025 | Monday | News
Orchestrating Scale In Cell And Gene Therapy From Trial Complexity To Commercial Reality

As cell and gene therapies move rapidly from pioneering clinical trials into commercial healthcare systems the industry is facing a defining inflection poi...

December 25, 2025 | Thursday | Interaction
T-MAXIMUM Pharmaceutical Secures FDA IND Clearance for Allogeneic B7-H3 CAR-T MT027 in Recurrent Glioblastoma

T-MAXIMUM Pharmaceutical announced that its proprietary allogeneic, B7-H3-targeted CAR-T therapy, MT027, has received IND Clearance from the U.S. Food an...

December 23, 2025 | Tuesday | News
Akadeum Launches CDMO Alliance With ElevateBio and Charles River as Inaugural Members

Cell therapy manufacturers Charles River and ElevateBio are named as inaugural members Akadeum Life Sciences, the leader in buoyant cell separation, ann...

December 10, 2025 | Wednesday | News
AstraZeneca Showcases Broad Advances in Blood Cancer and Rare Disease Care With 65 Presentations at ASH 2025

Investigational T-cell engager, surovatamig, and CAR T-cell therapy, AZD0120, will show potential with initial data across multiple blood cancers New ...

December 05, 2025 | Friday | News
Regeneron and Tessera Partner on One-Time Gene Writing Therapy for Alpha-1 Antitrypsin Deficiency

TSRA-196 is a potential one-time treatment to precisely correct the genetic mutation underlying AATD, with Investigational New Drug filing expected by ...

December 02, 2025 | Tuesday | News
Imugene and JW Therapeutics Collaborate on Innovative CF33-CD19 and CAR-T Therapy for Solid Tumors

Imugene and JW Therapeutics (Shanghai) Co., LTD have entered a strategic collaboration to evaluate a novel combination therapy using Imugene's onCARlyt...

December 01, 2025 | Monday | News
InnoCare Pharma Doses First Patient in Global Phase II Trial of Soficitinib for Prurigo Nodularis

InnoCare Pharma (HKEX: 9969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced tha...

December 01, 2025 | Monday | News
Kedrion Secures EMA Orphan Drug Designation for Investigational Aceruloplasminemia Therapy

  Kedrion announces that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its investigational treatment for Congenita...

November 28, 2025 | Friday | News
Sarepta Receives FDA Approval to Initiate Cohort 8 Evaluating Sirolimus With ELEVIDYS in Non-Ambulant Duchenne

Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to be...

November 26, 2025 | Wednesday | News
MDA Applauds FDA Approval of Itvisma, the First Gene Replacement Therapy for a Broad SMA Population

The Muscular Dystrophy Association (MDA)  called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve), ...

November 26, 2025 | Wednesday | News
EMD Serono Advances First Potential Oral gMG Therapy with FDA Fast Track Designation

  Cladribine capsules have the potential to be the first oral treatment for people living with rare, chronic autoimmune neuromuscular disorder, g...

November 25, 2025 | Tuesday | News

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