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325 News Found

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH
News | August 27, 2024

Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with PNH

PiaSky advances C5 inhibition through innovative recycling technology, which enables its monthly SC administration


Fasenra approved in China for the treatment of severe eosinophilic asthma
Drug Approval | August 25, 2024

Fasenra approved in China for the treatment of severe eosinophilic asthma

Approval based on MIRACLE Phase III trial demonstrating a significant and clinically meaningful reduction in asthma exacerbations and improvement in asthma symptom control


EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma
News | August 19, 2024

EMA validates Bristol Myers Squibb’s application for CAR T cell therapy Breyanzi for relapsed or refractory follicular lymphoma

Application based on the Transcend FL trial in which Breyanzi showed deep and durable responses and a consistent and well-established safety profile


Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer
Drug Approval | August 13, 2024

Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years


Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr
News | August 12, 2024

Ami Organics reports Q1FY25 PAT lower 34% at Rs. 14.7 Cr

Q1FY25 Revenue from Operations grew by 15% to Rs. 177 crore


Daiichi Sankyo and Merck enter into global agreement for MK-6070
News | August 07, 2024

Daiichi Sankyo and Merck enter into global agreement for MK-6070

To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights


Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg
Drug Approval | August 06, 2024

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


USAID and Takeda launch dengue prevention campaign
Public Health | July 27, 2024

USAID and Takeda launch dengue prevention campaign

Campaign launched to spread awareness regarding dengue prevention and control