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Results For "regulatory-authority"

61 News Found

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification
News | October 26, 2022

Biocon Biologics insulins facility in Malaysia receives EU GMP Certification

The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.


Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis
Clinical Trials | October 13, 2022

Dupixent Phase 3 data showed significant histological remission of eosinophilic esophagitis

68% of children on a higher dose of Dupixent achieved histological disease remission at week 16


Presss note on WHO Medical product alert regarding Maiden Pharmaceuticals
News | October 07, 2022

Presss note on WHO Medical product alert regarding Maiden Pharmaceuticals

DSCO has requested WHO to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question etc.


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