Search Results for medicines

Pfizer and BioNTech Granted Favorable CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union

Today, Pfizer and BioNTech announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY® JN.1, for active immunization against COVID-19 caused…

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Roche’s Vabysmo Receives CHMP Recommendation for Third Indication: Retinal Vein Occlusion (RVO)

Roche announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for extending the marketing authorization of Vabysmo® (faricimab) to include the treatment of visual impairment due to macular edema…

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Merck Gains Positive EU CHMP Opinion for WINREVAIR™ (Sotatercept) in Treating Pulmonary Arterial Hypertension (PAH)

Merck Announces Positive EU CHMP Recommendation for WINREVAIR™ (Sotatercept) in Treating Pulmonary Arterial Hypertension (PAH) Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of…

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EU Approves Truqap Plus Faslodex for Advanced ER-Positive Breast Cancer Treatment

AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has received approval from the European Union (EU) for treating adult patients with estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer that harbors one or more PIK3CA, AKT1, or PTEN…

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