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1261 News Found

CHMP recommends European Commission approval of Rinvoq
Drug Approval | May 23, 2022

CHMP recommends European Commission approval of Rinvoq

Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients


Merck KGaA to expand its membrane and filtration manufacturing facility in Ireland
News | May 23, 2022

Merck KGaA to expand its membrane and filtration manufacturing facility in Ireland

The company will invest approximately €440 million to increase membrane manufacturing capacity in Carrigtwohill and to build a new manufacturing facility at Blarney Business Park, both in Cork, Ireland


Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe
News | May 21, 2022

Novavax files for expanded conditional marketing authorisation for Nuvaxovid as a booster in Europe

The European Commission granted CMA in December 2021 for use of Nuvaxovid in individuals aged 18 and over, and Novavax filed for expanded CMA for use in adolescents aged 12 through 17 in March 2022


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


Novartis Cosentyx receives positive CHMP opinion for use in childhood arthritic conditions
Biotech | May 21, 2022

Novartis Cosentyx receives positive CHMP opinion for use in childhood arthritic conditions

Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU


Propanc Biopharma undertaking PRP manufacturing & development for human use
Biotech | May 20, 2022

Propanc Biopharma undertaking PRP manufacturing & development for human use

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas administered by intravenous injection


Grand Opening of Kodiak Sciences’ bioconjugation facility
Biotech | May 19, 2022

Grand Opening of Kodiak Sciences’ bioconjugation facility

Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases


Cytel designed and led TOGETHER trial wins Clinical Trial award
News | May 18, 2022

Cytel designed and led TOGETHER trial wins Clinical Trial award

Leading this effort was Cytel’s principal research scientist and Professor of Health Research Methods at McMaster University in Canada, Dr. Edward Mills


Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years
Drug Approval | May 18, 2022

Pfizer and BioNTech granted U.S. EUA for booster dose for kids 5-11 years

Children 5 through 11 years of age are now authorized to receive a booster dose at least five months after the second dose of the two-dose primary series


Themis Medicare gets add on approval for Viralex
Drug Approval | May 18, 2022

Themis Medicare gets add on approval for Viralex

Viralex (Inosine Pranobex) is an immunomodulatory agent with broad-spectrum antiviral properties