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2674 News Found

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


USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B
Drug Approval | October 12, 2024

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis


Alkem enters into licensing agreement with BioTherapeutics
News | October 11, 2024

Alkem enters into licensing agreement with BioTherapeutics

Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings


FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation
Drug Approval | October 11, 2024

FDA approves Roche’s Itovebi for treatment of HER2-negative breast cancer with a PIK3CA mutation

Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting


WHO declares India has eliminated Trachoma as a public health problem in 2024
Healthcare | October 10, 2024

WHO declares India has eliminated Trachoma as a public health problem in 2024

WHO estimates suggest that 150 million people worldwide are affected by Trachoma


Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries
Policy | October 09, 2024

Biocon Biologics’ sponsored report suggests ways to increase adoption of Biosimilars in poor countries

Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines


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


FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


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


Calquence granted priority review in US for patients with untreated mantle cell lymphoma
Drug Approval | October 06, 2024

Calquence granted priority review in US for patients with untreated mantle cell lymphoma

Based on ECHO Phase III trial which demonstrated Calquence combination reduced risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy