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Results For "therapy"

1495 News Found

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients


USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency
Drug Approval | November 16, 2024

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters


Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM
Drug Approval | November 16, 2024

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial


Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC
Drug Approval | October 16, 2024

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients


Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma
Clinical Trials | October 09, 2024

Aurigene Oncology gets positive results of Phase 1 study for CAR-T cell therapy for multiple myeloma

India’s first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma


AstraZeneca, CSPC Pharmaceutical agree for a pre-clinical novel lipid-lowering therapy
News | October 08, 2024

AstraZeneca, CSPC Pharmaceutical agree for a pre-clinical novel lipid-lowering therapy

CSPC will receive an upfront payment of $100 million from AstraZeneca


BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months
Clinical Trials | September 27, 2024

BlueRock Therapeutics’ investigational cell therapy bemdaneprocel for Parkinson’s disease shows positive data at 24-months

At 24 months, data from the Phase 1 exPDite trial continue to show a favorable safety profile in all 12 participants in the trial’s high and low dose cohorts


Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC
Clinical Trials | September 16, 2024

Keytruda plus chemotherapy before surgery reduced risk of death by more than 1/3versus neoadjuvant chemotherapy in high-risk early stage TNBC

KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival


FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy
Drug Approval | September 16, 2024

FDA approves Roche’s Tecentriq Hybreza, the first and only subcutaneous anti-PD-(L) cancer immunotherapy

Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous


AGC and Medinet sign agreement for cell therapy CDMO business
News | September 12, 2024

AGC and Medinet sign agreement for cell therapy CDMO business

A new initiative to contribute to enhancing drug discovery capabilities in the field of gene and cell therapy in Japan