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Results For "regulatory-authority"

61 News Found

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines
Drug Approval | April 23, 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies


Biocon receives approval from SAHPRA for Tacrolimus Capsule
News | April 22, 2024

Biocon receives approval from SAHPRA for Tacrolimus Capsule

Tacrolimus is an immunosuppressant used in the treatment of organ transplant patients


Pfizer announces positive results from Phase 3 Study of Abrysvo
Clinical Trials | April 12, 2024

Pfizer announces positive results from Phase 3 Study of Abrysvo

ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk.


Carbogen Amcis (Shanghai) completed ANVISA Audit
Drug Approval | March 19, 2024

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised


USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad
Drug Approval | March 02, 2024

USFDA inspects Shilpa Medicare’s bio-analytical laboratory in Hyderabad

This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently


Supriya Lifesciences received GMP certification from ANVISA Brazil
News | January 06, 2024

Supriya Lifesciences received GMP certification from ANVISA Brazil

The clearance of this audit marks the successful registration of 8 APIs with CADIFA


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Clinical Trials | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease


EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema
Drug Approval | August 21, 2023

EMA accepts LEO Pharma’s MAA for delgocitinib cream in chronic hand eczema

LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment


Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab
News | April 29, 2023

Biocon Biologics' new mAbs facility receives EU GMP Certification for bBevacizumab

This approval reflects Biocon Biologics' compliance with the highest international regulatory standards