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 ...
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 ...
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.
Zacks Investment Research on MSN

MRK gets positive CHMP opinion for expanded use of Winrevair in PAH

Merck MRK announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered ...

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, ...
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 ...

European health regulator recommends approval for GSK's twice yearly asthma drug

Dec 12 () - The European Medicines Agency has ​recommended the approval ‌of GSK's add-on drug to ‌treat asthma and a chronic ...

Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory Follicular Lymphoma

Incyte Announces European Commission Approval of Minjuvi® (tafasitamab) for the Treatment of Relapsed or Refractory ...