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 ...
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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 ...
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.
Medical Dialogues

Merck receives positive EU CHMP opinion for expanded use of Winrevair in adults with Pulmonary Arterial Hypertension

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the European Medicines Agency’s ...

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 ...
The Caledonian-Record

Cytokinetics Announces Positive CHMP Opinion of MYQORZO® (Aficamten) for the Treatment of ...

The CHMP recommendation for MYQORZO is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust ...
Pharmabiz

AstraZeneca’s Saphnelo approved in EU for subcutaneous self-administration as a new pre-filled pen for systemic lupus erythematosus

AstraZeneca’s Saphnelo (anifrolumab) has been approved in the European Union (EU) for subcutaneous self-administration as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE) on ...