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Ipsen Itching Drug Scratches Off a Second FDA Approval in Rare Liver Indication

Ipsen drug Bylvay is now FDA approved for treating pruritus, or severe itching, which is a complication of the rare liver disease Alagille syndrome. The oral drug was previously approved for treating pruritus in another rare inherited liver disease called PFIC.
France General Howard Mayer Committee For Medicinal Products Human European Medicines Agency Marengo Therapeutics Albireo Pharma

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GSK gets European approval for RSV vaccine

Pharmaceuticals giant GSK announced on Wednesday that the European Commission has granted authorisation for ‘Arexvy’ - an adjuvant respiratory syncytial virus (RSV) vaccine - for active immunisation to prevent RSV-caused lower respiratory tract disease (LRTD) in adults 60 and older.
Tony Wood European Commission Drug Administration Advisory Committee On Immunization Practices European Medicines Agency Medicinal Products

Fennec Pharmaceuticals Announces European Commission Marketing Authorization for Pedmarqsi (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients

06.06.2023 - Pedmarqsi is the First and Only Approved Therapy in the European Union for Reducing the Risk of Cisplatin-induced Hearing Loss (Ototoxicity) in Pediatric Patients with Localized, Non-metastatic Solid TumorsRESEARCH TRIANGLE PARK, N.C., June 06, ... Seite 1
Rosty Raykov Drug Administration European Commission Committee For Medicinal Products Human Use European Commission For Pedmarqsi European Union

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