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2552 News Found

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer
Drug Approval | January 29, 2024

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival


Glenmark Life Sciences inks CDMO supply deal with a Japanese pharma innovator
News | January 19, 2024

Glenmark Life Sciences inks CDMO supply deal with a Japanese pharma innovator

Glenmark Life Sciences will manufacture API in the therapeutic area of urinary anti-spasmodic, to supply to the global innovator


Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market
Drug Approval | January 19, 2024

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets


ARTBIO and PharmaLogic inks supply agreement for Lead-212 based Therapeutic Candidate for  treatment of prostate cancer
Supply Chain | January 15, 2024

ARTBIO and PharmaLogic inks supply agreement for Lead-212 based Therapeutic Candidate for treatment of prostate cancer

PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York


FDA grants priority review to Merck’s new biologics license application for V116
Drug Approval | December 20, 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults


INEOS Styrolution’s NAS Eco cuts CO2 emissions by 93% in healthcare application
Sustainability | December 03, 2023

INEOS Styrolution’s NAS Eco cuts CO2 emissions by 93% in healthcare application

The new ECO grade is made using renewable feedstock


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


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


Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
Drug Approval | October 09, 2023

Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib

The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials


Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule
Drug Approval | October 05, 2023

Asahi Kasei Pharma files application for approval to manufacture and sell Cresemba Capsule

The product is an additional formulation of Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg