EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s mNEXSPIKE (COVID-19 Vaccine, mRNA)

NEXSPIKE is Moderna’s third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and ...

Moderna, Inc.: EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's mNEXSPIKE

NEXSPIKE is Moderna's third product to receive a positive CHMP opinion alongside Spikevax (COVID-19 Vaccine, mRNA) and mRESVIA (Respiratory Syncytial Virus Vaccine)mNEXSPIKE will be available in the E ...
Zacks.com on MSN

MRK Gets Positive CHMP Opinion for Expanded Use of Winrevair in PAH

Merck secures a positive CHMP opinion to expand Winrevair's PAH use, potentially broadening treatment to adult patients ...
Medical Dialogues

Lupin receives positive EMA comittee opinion for eye therapy Ranluspec

Mumbai: Global pharma major Lupin Limited has announced that the Committee for Medicinal Products for Human Use (CHMP) of the ...
Pharmabiz

EMA committee recommends marketing approval for Lupin’s biosimilar ranibizumab

EMA committee recommends marketing approval for Lupin’s biosimilar ranibizumab: Our Bureau, Mumbai Wednesday, December 17, 2025, 14:40 Hrs [IST] Global pharma major Lupin Limite ...
CNBCTV18

Lupin clears major EU regulatory hurdle for biosimilar ranibizumab

Lupin said the Committee for Medicinal Products for Human Use (CHMP) has backed the approval of the biosimilar, to be ...
Medscape

Biosimilars for Retina and Inflammatory Disease Get EMA Nod

The European regulator has recommended marketing approval for Ranluspec and Gotenfia after studies confirm their safety, ...
Medscape

New Biologic Cleared for Severe Asthma and Nasal Polyps

Phase 3 studies point to sustained disease control in patients who remain symptomatic despite standard therapies.
Fierce Pharma

GSK's long-acting asthma med scores in suite of CHMP drug endorsements

GSK’s depemokimab, a long-acting biologic that’s key in the British pharma’s growth plan, has won an endorsement from ...

European Medicines Agency Committee Recommends Authorization of New Moderna Covid-19 Vaccine

Moderna on Monday said that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the marketing authorization of mNexspike, a new Covid-19 vaccine. The committee's ...
The Caledonian-Record

Merck Receives Positive EU CHMP Opinion for Expanded Use of WINREVAIR™ (sotatercept) in Adults with Pulmonary Arterial Hypertension (PAH, WHO* Group 1 Pulmonary Hypertension)

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the ...

Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of Obstructive Hypertrophic Cardiomyopathy

Final Decision from European Commission Expected in Q1 2026SOUTH SAN FRANCISCO, Calif., (GLOBE NEWSWIRE) -- Cytokinetics, ...