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Results For "regulatory"

1222 News Found

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer


Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer
Drug Approval | November 16, 2023

Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer

Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient


Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’
News | November 14, 2023

Biocon Biologics receives MHRA, UK Approval for Biosimilar Aflibercept ‘Yesafili’

Yesafili, received marketing authorization approval from the European Commission for the European Union


BioPhy launches AI platform to accelerate the drug development market
Digitisation | November 14, 2023

BioPhy launches AI platform to accelerate the drug development market

The company has raised US$4.5 million in funding for its AI operating system


Glenmark Pharma reports Q2 FY24 loss at Rs. 62 Cr
News | November 13, 2023

Glenmark Pharma reports Q2 FY24 loss at Rs. 62 Cr

European operations' revenue grew 58.4% to Rs 599.7 crore


SMS Pharmaceuticals reports robust Q2FY24 operational performance
News | November 10, 2023

SMS Pharmaceuticals reports robust Q2FY24 operational performance

Q2FY24 EBITDA up by 105% y-o-y at Rs. 28 crore


Indian pharmaceutical companies have become reliable and affordable suppliers of high-quality drugs: MoS Bhagwant Khuba
Policy | November 08, 2023

Indian pharmaceutical companies have become reliable and affordable suppliers of high-quality drugs: MoS Bhagwant Khuba

Lack of technology transfer stands out as a formidable barrier


Lupin Mandideep plant gets USFDA green signal
Drug Approval | November 01, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023


USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent
Drug Approval | October 26, 2023

USFDA accepts for review AstraZeneca’s supplemental biologics license application for self-administration of FluMist Quadrivalent

The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer