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Results For "regulatory-filing"

84 News Found

Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood


Aurobindo Pharma Q4 PAT drops 28% to Rs 576 Cr
News | June 06, 2022

Aurobindo Pharma Q4 PAT drops 28% to Rs 576 Cr

Active pharmaceutical ingredients revenue for the quarter was at Rs 913 crore


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


US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027
Drug Approval | June 01, 2022

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study


AbbVie showcases its leadership in Rheumatology research with new data across multiple inflammatory joint diseases
Biotech | May 24, 2022

AbbVie showcases its leadership in Rheumatology research with new data across multiple inflammatory joint diseases

The hybrid congress will take place from 1-4 June in Copenhagen, as well as virtually


USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis
Drug Approval | May 21, 2022

USFDA approves Dupixent as first treatment for 12 and older with eosinophilic esophagitis

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of USFDA’s Priority Review action date


Novavax submits variations to expand approval in Australia and New Zealand for adolescents
Biotech | May 08, 2022

Novavax submits variations to expand approval in Australia and New Zealand for adolescents

If granted, Nuvaxovid would be the first protein-based Covid-19 vaccine option for adolescents in Australia and New Zealand


Shionogi’s once-a-day Covid-19 anti-viral shows rapid virus clearance
Biotech | April 25, 2022

Shionogi’s once-a-day Covid-19 anti-viral shows rapid virus clearance

A separate global Phase 3 study of S-217622 is underway aiming to recruit participants globally to support regulatory filings this year


Porton Advanced and Sinorda Biomedicine collaborate for cell therapy development for solid tumours
Biotech | April 25, 2022

Porton Advanced and Sinorda Biomedicine collaborate for cell therapy development for solid tumours

Under the agreement, Porton Advanced will provide services to accelerate the development, production and registration of breakthrough cell therapies currently being developed by Sinorda Biomedicine


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