Tag: CHMP

EU CHMP Gives AstraZeneca Positive Opinion for DECLARE-TIMI 58 Cardiovascular Outcomes Data

AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapaglifl...

EU CHMP Issued a Positive Opinion to Add a Self-Administration Option for Fasenra

AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to add a self-administration option for Fasenra (benraliz...

CHMP Recommended Roche’s Tecentriq for Treatment of Metastatic Triple-Negative Breast Cancer

Roche announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane®;...

CHMP Recommends Treatment for Paediatric Type 2 Diabetes

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of children and adolescents aged 10 years or older with typ...

Two Celgene Meds Received CHMP Positive Opinion

Celgene Corporation, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’...

CHMP Supports New Dose of Keytruda

Merck, known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the appr...

EMA Comittee Backs Sanofi and Lexicon Diabetes Med

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the Marketing Authorization of Zynquista™ (sotagliflozin), developed by Sanofi a...

EU Advisors Recommend AstraZeneca and Merck’s Tablets

AstraZeneca and Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positi...

Pfizer Received Positive CHMP Opinion for NSCLC Treatment

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Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for LORVIQUA® (lorlatinib, approved in the U.S., C...

Sanofi and Regeneron Present Positive Opinion of CHMP for Asthma Treatment

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupi...

CHMP’s Positive Opinion for AbbVie Med

CHMP positive opinion, supported by data from the pivotal Phase 3 program evaluating more than 2,000 patients with moderate to severe plaque psoriasis, will now be reviewed by the European Commission....

Teva’s Migraine Drug Got CHMP Positive Opinion

Teva’s migraine drug Ajovy (fremanezumab) has moved closer to the EU market after the influential CHMP regulatory committee gave it the green light. The decision paves the way for European approval...

CHMP Accepts Roche’s NSCLC Drug

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Roche's Tecentriq (tezolizumab) - a monoclonal antibody designed to bind with a protei...

EMA Recommended AstraZeneca’s Type I Diabetes Drug

AstraZeneca’s Forxiga (dapagliflozin) has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) as an oral adjunct treatment to insulin i...

EC Approved Indian Orphan Drug

The European Commission (EC) has approved NaMuscla (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders from Indian drugmaker Lupin. Non-dys...

Another Positive CHMP Opinion from EMA for Pfizer

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Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabe...