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1166 News Found

CDSCO, NRAI meets WHO international standards for vaccine regulations
Policy | October 14, 2024

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI


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


Aster implements India’s first IOeRT for cancer care
Healthcare | October 09, 2024

Aster implements India’s first IOeRT for cancer care

To set a new standard in oncology, offering highly targeted radiation therapy that improves treatment precision, and accelerates recovery for cancer patients


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


Jubilant Biosys signs and issues a put option offer to Pierre Fabre Laboratories
News | October 06, 2024

Jubilant Biosys signs and issues a put option offer to Pierre Fabre Laboratories

The acquisition will strengthen the overall company’s position as leading global CRO services partner


Briefs: Aurobindo Pharma and Lupin
News | October 06, 2024

Briefs: Aurobindo Pharma and Lupin

USFDA completes PAI of Lupin’s biotech facility in Pune


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


Lupin signs distribution agreement with Celnova for orphan drug NaMuscla
Supply Chain | September 28, 2024

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia