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Results For "regulatory-approval"

338 News Found

WHO urges rapid expansion of new HIV prevention tools amid funding crisis
Healthcare | December 03, 2025

WHO urges rapid expansion of new HIV prevention tools amid funding crisis

Despite steep funding setbacks, the global HIV response has gained momentum in 2025 with the introduction of twice-yearly injectable LEN


Piramal Pharma Solutions achieves global nitrosamine compliance, strengthening patient safety
News | November 28, 2025

Piramal Pharma Solutions achieves global nitrosamine compliance, strengthening patient safety

Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight


GE HealthCare to acquire Intelerad for $2.3 billion, expanding cloud and AI imaging footprint
Healthcare | November 25, 2025

GE HealthCare to acquire Intelerad for $2.3 billion, expanding cloud and AI imaging footprint

The deal accelerates GE HealthCare’s digital transformation, expanding its reach into outpatient care and enterprise imaging—a $2 billion-plus growth market


AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients
Drug Approval | November 21, 2025

AbbVie’s EPKINLY gains FDA nod for relapsed follicular lymphoma, offering new hope for patients

The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study


Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial
Clinical Trials | November 21, 2025

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration


FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer
Drug Approval | November 14, 2025

FDA approves Promega’s OncoMate test to guide personalised treatment for endometrial cancer

OncoMate MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in tumor tissue


Shilpa Medicare announces positive Phase 3 results for Oeris
Clinical Trials | November 12, 2025

Shilpa Medicare announces positive Phase 3 results for Oeris

OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days


Teva reports 11th consecutive quarter of growth
News | November 06, 2025

Teva reports 11th consecutive quarter of growth

Teva reported third quarter revenues of $4.5 billion, an increase of 3 per cent year-over-year.


Kimberly-Clark to acquire Kenvue in $48.7 billion mega deal
News | November 04, 2025

Kimberly-Clark to acquire Kenvue in $48.7 billion mega deal

Upon completion, Kimberly-Clark shareholders are expected to own about 54% of the combined entity, while Kenvue shareholders will hold the remaining 46%