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Results For "regulatory-filing"

90 News Found

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


Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib
Biotech | March 01, 2022

Innovent Biologics and AnHeart Therapeutics receive NMPA breakthrough designation for taletrectinib

The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors


Novavax ships first consignment of Covid-19 vaccine to European countries
News | February 24, 2022

Novavax ships first consignment of Covid-19 vaccine to European countries

The first wave of shipments includes several countries, such as Germany, France and Austria


UK MHRA approves Marksans  All in One oral solution
Drug Approval | February 22, 2022

UK MHRA approves Marksans All in One oral solution

Therapeutic use of the product is for short term symptomatic relief of colds, chills and influenza including chesty coughs


Infinity Holding Group to acquire 43.7 per cent stake in Jagsonpal Pharma
News | February 22, 2022

Infinity Holding Group to acquire 43.7 per cent stake in Jagsonpal Pharma

The transaction as well as the open offer is expected to be completed by June this year.