European Medicines Agency

AstraZeneca Plc (NASDAQ:AZN) and Amgen Inc.'s (NASDAQ:AMGN) Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The Committee for Medicinal Products for Human Use (CHMP) of the European...

Aridis Pharmaceuticals Inc (NASDAQ: ARDS) shares are gaining after announcing positive European Medicines Agency feedback on its proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301. AR-301 is being developed as an adjunctive therapy with...

On Tuesday, the European Union’s drug regulator expanded its investigation into the risk of suicidal thoughts and self-injury among patients taking weight loss and diabetes medications, including those produced by Novo Nordisk (NASDAQ:NVO). The probe now encompasses about 150 reported cases...

The EU's drugs watchdog, the European Medicines Agency, recently raised a thyroid cancer safety signal for Novo Nordisk A/S (NYSE: NVO) drugs, including the much talked semaglutide used in Ozempic and Wegovy for weight loss. The safety signal indicates the EMA's...

The European Commission has approved Roche Holdings AG's (OTC: RHHBY) Xofluza (baloxavir marboxil) in children aged one year and above for uncomplicated influenza and post-exposure prophylaxis of influenza.  Post-exposure prophylaxis aims to prevent influenza in individuals...

The European Commission has approved AstraZeneca Plc (NASDAQ: AZN) and Merck & Co Inc's (NYSE: MRK) Lynparza (olaparib) plus abiraterone and prednisone or prednisolone for metastatic castration-resistant prostate cancer (mCRPC) for patients for whom chemotherapy is...

The European Commission (EC) has expanded the marketing authorization of Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi SA's (NASDAQ: SNY) Dupixent (dupilumab) for moderate-to-severe prurigo nodularis. Prurigo nodularis is a chronic, debilitating skin disease...

The European Commission has approved Mirum Pharmaceuticals Inc's (NASDAQ: MIRM) Livmarli (maralixibat) oral solution for cholestatic pruritus in patients with Alagille syndrome (ALGS) two months of age and older. ALGS is a rare genetic disorder in which bile ducts are abnormally...

The European Commission has approved Sanofi SA (NASDAQ: SNY) Enjaymo (sutimlimab) for hemolytic anemia in adult patients with cold agglutinin disease (CAD). CAD is a rare chronic autoimmune hemolytic anemia, where the body's immune system mistakenly attacks healthy red blood...

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approving AstraZeneca Plc (NASDAQ: AZN) - Merck & Co Inc (NYSE: MRK) partnered Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone...

The European Commission has approved Agios Pharmaceuticals Inc's (NASDAQ: AGIO) Pyrukynd (mitapivat) for PK deficiency in adult patients.  Pyrukynd is a first-in-class, oral PK activator and the first approved disease-modifying therapy for patients in the EU with this rare...

The European Commission has approved Sanofi SA (NASDAQ: SNY) and GSK plc (NYSE: GSK) partnered COVID-19 vaccine booster after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion. The shot with the brand...

The European Commission has approved AstraZeneca plc (NASDAQ: AZN) and Sanofi SA’s (NASDAQ: SNY) Beyfortus (nirsevimab) long-acting antibody to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV...

The European Medicine Agency's safety committee recommended that a group of JAK inhibitors for chronic inflammatory disorders be only used in certain at-risk patients if no alternatives are available. Following the FDA's issuance of a safety warning regarding JAK inhibitors, the...

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed conditional approval for Moderna Inc's (NASDAQ: MRNA) updated omicron BA.4-5 COVID-19 vaccine booster for 12 years and above. This vaccine now joins Moderna's other updated...