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2385 News Found

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer
Drug Approval | March 30, 2024

NMPA accepts supplemental Biologics License Application for enfortumab vedotin with Keytruda for treatment of bladder cancer

If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy


UBE announces Phase I clinical trial for SSAO/VAP-1 licensed exclusively to Novo Nordisk
Clinical Trials | February 15, 2024

UBE announces Phase I clinical trial for SSAO/VAP-1 licensed exclusively to Novo Nordisk

MASH is a chronic and progressive liver disease characterised by fat accumulation and inflammation in the liver,


Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab
News | January 29, 2024

Jiangsu Alphamab, 3D Medicines and Glenmark sign license agreement for Envafolimab

Glenmark will be responsible for further developing, registering, and commercializing Envafolimab in India, Asia Pacific, Middle East and Africa, Russia, CIS, and Latin America


Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg
Drug Approval | January 18, 2024

Zydus receives USFDA’s approvals for Pimavanserin Capsules, 34 mg and Pimavanserin Tablets,10 mg

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis


Shanghai Argo announces multi-program RNAi licenses with Novartis
News | January 11, 2024

Shanghai Argo announces multi-program RNAi licenses with Novartis

Argo will receive upfront payments of US$ 185 million from Novartis and is eligible to receive potential option and milestone payments as well as tiered royalties on commercial sales.


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


DxVx plans to make a license-in agreement of OVM-200
News | November 25, 2023

DxVx plans to make a license-in agreement of OVM-200

Final stage in licensing OVM-200 from Oxford Vacmedix in the UK


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


Venus Remedies earns REO Certification from CII for second consecutive year
News | October 26, 2023

Venus Remedies earns REO Certification from CII for second consecutive year

The Responsible Export Organisation (REO) certification is a distinguished recognition awarded by the Confederation of Indian Industry (CII)