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646 News Found

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer
Drug Approval | March 07, 2024

EMA validates MAAs for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in two types of cancer

The validations confirm the completion of the applications and commence the scientific review process


Bayer strengthens pharma portfolio with new cardiology drug acoramidis
News | March 06, 2024

Bayer strengthens pharma portfolio with new cardiology drug acoramidis

Acquisition of exclusive commercialization rights for European markets


Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility
Drug Approval | February 26, 2024

Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The observations do not pose any risk to site's compliance standards or its business continuity


Orchid Pharma's 'Exblifep' receives USFDA approval
Drug Approval | February 24, 2024

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA


MIRA Pharmaceuticals announces collaboration with Pharmaseed
News | February 08, 2024

MIRA Pharmaceuticals announces collaboration with Pharmaseed

Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024


Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Drug Approval | January 31, 2024

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis


Taro announces merger agreement with Sun Pharma
News | January 18, 2024

Taro announces merger agreement with Sun Pharma

Agreed Price of US$43 per share to deliver 48% premium to unaffected price on May 25, 2023


CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'
News | January 17, 2024

CuraTeQ Biologics receives recommendation for grant of marketing authorization of 'biosimilar trastuzumab'

Trastuzumab biosimilar is a humanized monoclonal antibody for treating metastatic breast cancer


Briefs: Venus Remedies and Shivalik Rasayan
News | January 13, 2024

Briefs: Venus Remedies and Shivalik Rasayan

Shivalik Rasayan Limited have successfully submitted USMDF for API " Palbociclib " to USFDA


USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer
Drug Approval | January 10, 2024

USFDA accepts sBLA of TIVDAK for priority review for patients with metastatic cervical cancer

Submission based on positive results from global phase 3 study demonstrating overall survival benefit of TIVDAK over chemotherapy