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Investegate |F. Hoffmann-La Roche Ltd Announcements | F. Hoffmann-La Roche Ltd: CHMP recommends EU approval of Roche's fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma

April 26, 2023
Investegate announcements from F. Hoffmann-La Roche Ltd, CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma
United States Nathalie Altermatt Loren Kalm Levi Garraway Roche Group European Commission
Source: investegate.co.uk

Glofitamab Approaches EU Approval for R/R Diffuse Large B-cell Lymphoma

April 26, 2023
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of glofitamab for fixed-duration use in adult patients with relapsed or refractory diffuse large B-cell lymphoma following 2 or more lines of systemic therapy.
Levi Garraway Health Canada Global Product Development At Roche European Medicines Agency Medicinal Products Human Use
Source: onclive.com

Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval for CAMZYOS® (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (HCM)

April 26, 2023
If approved, CAMZYOS would be the first cardiac myosin inhibitor in Europe that specifically targets the source of obstructive HCM Recommendation based on positive Phase 3 EXPLORER-HCM and... | June 18, 2023
Roland Chen Bristol Myers Squibb York Heart Association Committee For Medicinal Products Human Use European Commission Exchange Commission
Source: marketscreener.com

Amicus Therapeutics Receives Positive CHMP Opinion for Opfolda® (miglustat) for Late-Onset Pompe Disease

April 26, 2023
        European Commission Approval of Opfolda and Commercial Launch of Pombiliti® + Opfolda® Anticipated in 3Q 2023 Upon Approval, Pombiliti + Opfolda will be the... | April 26, 2023
United States Andrew Faughnan Bradley Campbell Johnf Crowley Diana Moore European Commission Approval Of Opfolda
Source: marketscreener.com

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Novartis Cosentyx gains positive CHMP opinion for hidradenitis suppurativa

April 26, 2023
26.04.2023 - Positive opinion paves way for first new treatment option in hidradenitis suppurativa (HS) in nearly a decade Committee for Medicinal Products for Human Use (CHMP) opinion based on robust Phase III data showing Cosentyx (secukinumab) provided ... Seite 1
Staedtisches Klinikum Dessau Barry Mcgrath Brandenburg Medical School Drug Administration European Medicines Agency Committee For Medicinal Products Human Use
Source: wallstreet-online.de

Ascentage Pharma Passes GMP Compliance Audit by EU QP with Zero Deficiency, in an Achievement Signaling Global Recognition of the Company's Quality Management System

April 25, 2023
/PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB),...
Hong Kong Western Australia Prnewswire Ascentage Pharma Ascentage Pharma Dajun Yang Ascentage Pharma Global Manufacturing Center
Source: prnewswire.com

NanoViricides, Inc.: NanoViricides is Expanding its Broad-Spectrum Antiviral Program to Explore Further Antiviral Applications of its COVID Clinical Drug Ingredient

April 25, 2023
SHELTON, CT / ACCESSWIRE / April 25, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage global leader in the development of highly effective antiviral therapies based on
United States Tapparelc Heparan Nanoviricides Inc Securities Exchange Theracour Pharma Inc Committee For Medicinal Products Human
Source: finanznachrichten.de

GSK says Europe watchdog backs marketing authorisation application

April 25, 2023
GSK PLC on Tuesday said the European Medicines Agency has validated its marketing authorisation application for its dostarlimab drug, marketed as Jemperli. The London-based pharmaceutical firm said... | April 25, 2023
City Of United Kingdom Harvey Dorset Committee For Medicinal Products Human European Medicines Agency Global Head Of Oncology Development Hesham Abdullah
Source: marketscreener.com

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