Tag Archives: 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 (EMA) has recommended granting marketing authorization for Fabhalta® (iptacopan) for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) who … Read the full press release

GSK’s Jemperli Receives Positive CHMP Opinion for Frontline Treatment of Advanced Endometrial Cancer with Chemotherapy

(IN BRIEF) GSK has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Jemperli (dostarlimab) in combination with chemotherapy as a frontline treatment for adult … Read the full press release

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 per i medicinali ha raccomandato l’autorizzazione all’immissione in commercio nell’Unione europea di darolutamide, un inibitore orale del recettore degli androgeni, … Read the full press release

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 has recommended darolutamide, an oral androgen receptor inhibitor, for marketing authorization in the European Union as a treatment for patients … Read the full press release

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 bio is still in the process of being reviewed by CHMP during their 25-28 March 2019 meeting. An opinion for … Read the full press release

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 dermatology Positive opinion is based on comprehensive clinical and non-clinical data that is expected to confirm that Sandoz biosimilar infliximab … Read the full press release

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 percent compared to bendamustine alone BASEL, 04-May-2016 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the EU … Read the full press release

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 Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder. CAZ … Read the full press release

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 benefit in achieving pathological complete response (pCR) BASEL, 29-6-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced … Read the full press release

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 give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It … Read the full press release