Latest News for: chmp
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The CHMP adopted a positive opinion for Vueway® (gadopiclenol) for its use in pediatric patients under 2 years of age
PR Newswire 19 Dec 2025
On 11 December 2025, the CHMP adopted in EU a positive opinion for the extension of the existing indications to infants and young children, including neonates, reinforcing its established safety and diagnostic performance.
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Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector
Business Wire 18 Dec 2025
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December 17, 2025 Lupin Receives Positive CHMP Opinion for Biosimilar Ranibizumab (Lupin Limited)
Public Technologies 17 Dec 2025
Thierry Volle, President EMEA and Emerging Markets, Lupin, said, "We are very pleased with the CHMP's positive opinion for ranibizumab ... The CHMP positive opinion will now be considered by the European Commission (EC).
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Morgan Citizen
13 Dec 2025
Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion
Positive opinion from European Medicines Agency supports ...
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The Milton Standard Journal
12 Dec 2025
Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with ...
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Cytokinetics Announces Positive CHMP Opinion of MYQORZO� (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy
Nasdaq Globe Newswire 12 Dec 2025
Final Decision from European Commission Expected in Q1 2026 ... .
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Enid News & Eagle
12 Dec 2025
Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of
Final Decision from European Commission Expected in Q1 2026 ... .
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GSK's RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older (Form 6-K) (GSK plc)
Public Technologies 12 Dec 2025
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Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion (STADA Arzneimittel AG)
Public Technologies 12 Dec 2025
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Sobi Receives Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of C3G and Primary IC-MPGN (Swedish Orphan Biovitrum AB)
Public Technologies 12 Dec 2025
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Sobi Receives Positive CHMP Opinion for Aspaveli® (pegcetacoplan) for the Treatment of C3G and Primary IC-MPGN
PR Newswire 12 Dec 2025
The positive opinion from the CHMP is now referred to the European Commission for an approval decision, which is expected in the first quarter of 2026 ... "The CHMP's positive opinion for Aspaveli ...
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Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)
Pharmiweb 12 Dec 2025
The CHMP recommendation will now be reviewed by the European Commission (EC) for amending the marketing authorization in the EU, Iceland, Liechtenstein and Norway, and a final decision is expected in the first quarter of 2026.
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Nucala (mepolizumab) receives positive CHMP opinion for treatment of chronic obstructive pulmonary disease (COPD) (Form 6-K) (GSK plc)
Public Technologies 12 Dec 2025
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Depemokimab receives positive CHMP opinion for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (Form 6-K) (GSK plc)
Public Technologies 12 Dec 2025- 1
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