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Results For "regulatory-affairs"

59 News Found

Elucid appoints Kelly Huang as CEO
People | July 22, 2024

Elucid appoints Kelly Huang as CEO

Experienced commercial leader takes helm to expand cardiovascular diagnostic company globally and commercialize company’s flagship plaque analysis software


AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer
People | July 10, 2024

AbbVie appoints Roopal Thakkar as EVP, Research & Development and Chief Scientific Officer

Dr. Roopal Thakkar joined Abbott/AbbVie in 2003 as part of the Physician Development Program


USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
News | April 17, 2024

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections


Qure.ai adds new FDA breakthrough device status for qSpot-TB
Digitisation | February 09, 2024

Qure.ai adds new FDA breakthrough device status for qSpot-TB

4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months


Biocon Academy conducts 8th Graduation Day
News | December 19, 2023

Biocon Academy conducts 8th Graduation Day

Five batches across four programs of Biocon Academy participated in the graduation ceremony


Pradeep Chakravarty joins Alembic Pharmaceuticals as Head - Global Quality
People | December 05, 2023

Pradeep Chakravarty joins Alembic Pharmaceuticals as Head - Global Quality

Prior to joining Alembic, he was working with Lupin Limited for more than 11 years


BioPhy launches AI platform to accelerate the drug development market
Digitisation | November 14, 2023

BioPhy launches AI platform to accelerate the drug development market

The company has raised US$4.5 million in funding for its AI operating system


Clariant launches new range of excipients to improve stability and solubility of APIs at CPHI Barcelona
News | October 19, 2023

Clariant launches new range of excipients to improve stability and solubility of APIs at CPHI Barcelona

New effective carrier systems for drug delivery in different dosage applications including oral, topical & parenteral


Kivo launches unified DMS platform ‘Kivo GO’
News | September 27, 2023

Kivo launches unified DMS platform ‘Kivo GO’

Kivo’s expanded platform brings compliant collaboration and intelligent process automation to emerging Regulatory, Clinical and Quality teams