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Results For "regulatory-authority"

58 News Found

Mylab receives approval for HPV RT-PCR test for cervical cancers
Clinical Trials | September 28, 2022

Mylab receives approval for HPV RT-PCR test for cervical cancers

‘PathoDetect HPV Detection Test’ detects and discriminates the presence of high-risk HPV strains including 16 and 18 which cause most of the cervical cancers.


Allurion launches weight management solution in India
News | September 09, 2022

Allurion launches weight management solution in India

The Allurion Program is suited for people who are unable to achieve their weight-loss goals by dieting alone or for those who do not want to, or cannot, undergo invasive surgery or endoscopy


USFDA approves first treatment option for generalized pustular psoriasis flares in adults
Drug Approval | September 03, 2022

USFDA approves first treatment option for generalized pustular psoriasis flares in adults

Spesolimab is a monoclonal antibody that inhibits interleukin-36 (IL-36) signaling and is the first treatment specifically approved for the treatment of generalized pustular psoriasis flares


Biocon Biologics receives EU GMP Certification for its in Bengaluru
News | July 06, 2022

Biocon Biologics receives EU GMP Certification for its in Bengaluru

This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing.


Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for HIV in South Africa
Public Health | June 15, 2022

Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for HIV in South Africa

This new formulation represents a significant improvement over protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades.


USFDA accepts dupilumab for priority review in adults with prurigo nodularis
Drug Approval | June 01, 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved


HPRA completes audit of Biocon Biologics New mAbs drug substance facility
Biotech | May 04, 2022

HPRA completes audit of Biocon Biologics New mAbs drug substance facility

The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency


Malaysia awards three-year contract for Biocon Biologics’ Insugen
Biotech | April 26, 2022

Malaysia awards three-year contract for Biocon Biologics’ Insugen

Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics


Phase 3 data show Dupixent improves signs and symptoms of prurigo nodularis
Biotech | March 27, 2022

Phase 3 data show Dupixent improves signs and symptoms of prurigo nodularis

There are currently no approved systemic treatments for prurigo nodularis; regulatory filings for prurigo nodularis planned in the first half of 2022


Department of Pharmaceuticals release code to regulate medical devices sector
News | March 17, 2022

Department of Pharmaceuticals release code to regulate medical devices sector

If the government feels that the industry is not complying with the uniform code, it will consider making it a statutory code