CHMP

Novartis’ Fabhalta Receives Positive CHMP Opinion for PNH Treatment: A Potential Game-Changer

(IN BRIEF) Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…

1 month ago

Nuovi progressi nel trattamento del cancro alla prostata: Darolutamide sta per essere approvato nell’UE

Non destinato ai media statunitensi e britannici (NOTIZIA IN BREVE) Il comitato per i medicinali per uso umano dell'Agenzia europea…

1 year ago

New Advancement in Prostate Cancer Treatment: Darolutamide Set to be Approved in EU

Not intended for U.S. and UK Media (IN BRIEF) The European Medicines Agency's Committee for Medicinal Products for Human Use…

1 year ago

Associazione Veneta Lotta alla Talassemia (AVLT) and the UK Thalassaemia Society (UKTS) Clarification on European Regulatory Status of LENTIGLOBIN™

(PRESS RELEASE) LONDON, 27-Mar-2019 — /EuropaWire/ — The LentiGlobin application for Conditional Marketing Authorization (cMAA) at the EMA from bluebird…

5 years ago

Sandoz: EMA Committee for Medicinal Products for Human Use (CHMP) adopts positive opinion for marketing authorization of infliximab

Sandoz is seeking approval of biosimilar infliximab for use in all indications of its reference medicine across gastroenterology, rheumatology and…

6 years ago

EU Committee for Medicinal Products for Human Use (CHMP) recommends EU approval of Roche’s Gazyvaro for people with previously treated follicular lymphoma

In the pivotal study, treatment with Gazyvaro plus bendamustine chemotherapy reduced the risk of disease worsening or death by 52…

8 years ago

AstraZeneca announces positive CHMP opinion recommending the approval of new antibiotic, CAZ AVI

LONDON, 02-May-2016 — /EuropaWire/ — AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European…

8 years ago

Roche’s Perjeta recommended for approval in EU as pre-surgery breast cancer treatment

The Perjeta regimen is the first neoadjuvant (pre-surgery) breast cancer treatment recommended for approval in the EU based on the…

9 years ago

European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

London, 23-10-2012 — /europawire.eu/ — The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to…

12 years ago