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Results For "European-Medicines-Agency"

207 News Found

LintonPharm to release data on Catumaxomab at ASCO meeting
Biotech | May 30, 2022

LintonPharm to release data on Catumaxomab at ASCO meeting

The abstract is about the cohort A, stage I of the ongoing global phase ? trial that evaluating the safety and efficacy of Catumaxomab in advanced GC patients with peritoneal metastasis


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


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


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


Moderna announces advancements in mRNA platform science for application across multiple diseases
Biotech | May 17, 2022

Moderna announces advancements in mRNA platform science for application across multiple diseases

Moderna continues to expand its mRNA platform for a range of additional clinical applications and routes of administration including a modality for lung delivery


CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment
Drug Approval | April 23, 2022

CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment

If approved, Tecentriq will be the first and only cancer immunotherapy available for certain people with early-stage NSCLC in Europe


CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer
Biotech | April 23, 2022

CHMP adopts positive opinion on Tabrecta for advanced non-small cell lung cancer

With one of the most diverse lung cancer development programs, Novartis is focused on investments to advance the science, drive treatment and make an impact on patients


Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
Biotech | April 01, 2022

Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion

Celerity Pharmaceuticals uses Biocon Biologics’ insulin drug substance to develop the product