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Results For "European"

924 News Found

UK authorises first Covid-19 pill
News | November 05, 2021

UK authorises first Covid-19 pill

Applications remain under review by others including U.S. Food and Drug Administration and the European Medicines Agency


EMA encourages companies to submit type I variations by end- November
Policy | November 01, 2021

EMA encourages companies to submit type I variations by end- November

Marketing authorisation holders are advised to submit any type IB variations or groupings of type IBs and type IAs by 3rd December 2021 for a start of procedure in 2021


Boehringer Ingelheim announces EMA marketing authorisation for spesolimab
Drug Approval | October 29, 2021

Boehringer Ingelheim announces EMA marketing authorisation for spesolimab

Generalized pustular psoriasis is characterized by episodes of widespread eruptions of painful, sterile pustules


Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah
Biotech | October 28, 2021

Novartis receives priority review by U.S. FDA and filing acceptance by EMA for Kymriah

Kymriah, the first-ever FDA-approved CAR-T cell therapy, is currently available in 30 countries in one or more indications


We are marketing all our products globally: Samit Jain, MD, PLUSS
interviews | October 25, 2021

We are marketing all our products globally: Samit Jain, MD, PLUSS

Pluss Advanced Technologies (PLUSS), has led the growth of energy storage materials across applications. Their proprietary Phase Change Material has gained wide acceptance in the pharmaceutical, logistics and food industries. The varied demands of the industry during Covid-19 has brought its technology into focus. Samit Jain, MD, PLUSS in conversation with Thomas C Thottathil discusses trends and outlines his plans for the business


U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years
Drug Approval | October 22, 2021

U.S. FDA expands approval of Dupixent to include children aged 6 to 11 years

Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option


Zydus announces update on a randomised trial of Saroglitazar Mg in NASH
Biotech | October 22, 2021

Zydus announces update on a randomised trial of Saroglitazar Mg in NASH

Incidences of Non-alcoholic Fatty Liver Disease (NAFLD) have been rising exponentially worldwide and are associated with co-morbidities including obesity, diabetes, hypertension and metabolic disorders


Glenmark launches Tavulus for COPD treatment in Spain
Drug Approval | October 11, 2021

Glenmark launches Tavulus for COPD treatment in Spain

It is one of the first companies to launch a bioequivalent version of the dry powder inhaler and it's part of the company’s strategic exclusive in-licensing arrangement to market Tiotropium DPI in Western Europe and the UK


Lincoln Pharma gets Australian TGA approval
News | October 08, 2021

Lincoln Pharma gets Australian TGA approval

The company plans to expand its portfolio in regulated markets aggressively


EMA authorises booster dose of Moderna’s Spikevax
Drug Approval | October 06, 2021

EMA authorises booster dose of Moderna’s Spikevax

A growing number of studies have shown the benefit of a third dose of Covid-19 vaccine in immunocompromised subjects