Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 21

Results For "European-Union"

214 News Found

Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years
News | November 10, 2021

Moderna seeks approval from EMA for its Covid-19 vaccine for children between 6-11 years

The submission is based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11


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


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


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


Roche receives positive CHMP opinion for Gavreto
Drug Approval | September 18, 2021

Roche receives positive CHMP opinion for Gavreto

If approved, Gavreto will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC


BMS receives positive CHMP opinion for Opdivo
Drug Approval | September 18, 2021

BMS receives positive CHMP opinion for Opdivo

The recommendation is based on positive results from the pivotal Phase 3 CheckMate -649 trial in which Opdivo plus chemotherapy demonstrated superior overall survival versus chemotherapy


Prevest DenPro Limited's IPO to open on BSE SME platform on September 15
Clinical Trials | September 14, 2021

Prevest DenPro Limited's IPO to open on BSE SME platform on September 15

The net proceeds from the issue will be utilised towards the purchase of machinery, modernising existing units and expansion of its R&D facilities


Zymo Research receives CE Mark for new Covid-19 SafeCollect kits
Drug Approval | September 01, 2021

Zymo Research receives CE Mark for new Covid-19 SafeCollect kits

Self-collection devices designed for ease of use and safety


Japan approves AstraZeneca’s Forxiga for chronic kidney disease
Drug Approval | August 28, 2021

Japan approves AstraZeneca’s Forxiga for chronic kidney disease

Over 13 million people in Japan suffer from chronic kidney disease and this will transform treatment options


Pfizer receives EC approval for XEIJANZ
Biotech | August 23, 2021

Pfizer receives EC approval for XEIJANZ

XELJANZ is the first and only Janus kinase (JAK) inhibitor approved in Europe for the treatment of polyarticular JIA and juvenile PsA and has received regulatory approval in four indications in the European Union, the most of any JAK inhibitor