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 ...

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 ...
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, ...

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 ...
Zacks Investment Research on MSN

CHMP backs higher-dose Wegovy as Novo Nordisk seeks 2026 EU approval

Novo Nordisk NVO announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) ...
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.
The Pharma Letter

Saphnelo approved in the EU for sc self-administration

UK pharma major AstraZeneca today revealed that Saphnelo (anifrolumab) has been approved in the European Union (EU) for ...
The Joplin Globe

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 ...
TipRanks on MSN

Moderna saus CHMP adopts positive opinion for mNEXSPIKE

Moderna (MRNA) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion ...

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, ...
Pharmabiz

EMA committee recommends approval of an expanded indication for Merck’s Winrevair in adults with pulmonary arterial hypertension

EMA committee recommends approval of an expanded indication for Merck’s Winrevair in adults with pulmonary arterial hypertension: Rahway, New Jersey Monday, December 15, 2025, 1 ...