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924 News Found

Philogen withdraws marketing authorization application for Nidlegy in EU
News | June 26, 2025

Philogen withdraws marketing authorization application for Nidlegy in EU

The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls


Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia
News | June 21, 2025

Biogen initiates Phase 3 pediatric study of Omaveloxolone for treatment of Friedreich Ataxia

BRAVE study will explore the potential of omaveloxolone to address the critical unmet need of the pediatric FA population


Bristol Myers Squibb presents data across targeted protein degradation research at EHA 2025
News | June 16, 2025

Bristol Myers Squibb presents data across targeted protein degradation research at EHA 2025

Innovative agents highlight growth of targeted protein degradation platform and BMS' leadership in innovative cancer therapies


AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia
News | June 07, 2025

AstraZeneca’s fixed-duration Calquence-based regimens approved in EU for patients with chronic lymphocytic leukaemia

AMPLIFY Phase III trial results demonstrated statistically significant and clinically meaningful improvement in progression-free survival for Calquence combinations


Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC
News | June 07, 2025

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC

If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference


Sigachi Industries FY25 revenue surges 25%, EBITDA 46%
News | June 02, 2025

Sigachi Industries FY25 revenue surges 25%, EBITDA 46%

Newly commissioned MCC in Jhagadia and Dahej and CCS project expansions will unlock an additional 8,800 MTPA, fuelling year-over-year revenue gains of 20%-30% in excipients


Sudeep Pharma acquires Nutrition Supplies Services
News | May 30, 2025

Sudeep Pharma acquires Nutrition Supplies Services

This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio


Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’
Drug Approval | May 29, 2025

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’

Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA