EMA
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EMA warns of rising dangers from unregulated advanced therapies
ATMPs consist of innovative treatments developed from cells, genes, or tissues and are often utilized for rare diseases and certain types of cancer.
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EMA recommends conditional approval for Pfizer’s Elrexfio in treating multiple myeloma
NETHERLANDS — The European Medicines Agency (EMA) announced on Friday that its drug advisory panel has endorsed a conditional marketing authorization for Pfizer’s Elrexfio (elranatamab)…
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Novartis pulls sickle cell drug Adakveo from European market following regulatory reversal
EUROPE — A regulatory upheaval has led pharmaceutical giant Novartis to withdraw its sickle cell disease drug, Adakveo, from the European market. This decision comes…
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Fresenius Kabi breaks new ground with EMA’s backing for its game-changing Tocilizumab biosimilar
GERMANY —Fresenius Kabi, a renowned global healthcare company specializing in biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs, has achieved a major milestone with…
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GSK’s revolutionary long-acting HIV drug poised for European approval
BELGIUM — In a groundbreaking development, global pharmaceutical giant GSK has made a significant stride in the fight against HIV. Its majority-owned subsidiary, ViiV Healthcare,…
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European Commission takes action to prevent antibiotic shortages, while US grapples with penicillin supply strains
BELGIUM —The European Commission is proactively addressing potential shortages of key antibiotics by collaborating with manufacturers and healthcare providers, aiming to prevent supply shortfalls during…
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European watchdog initiates review on Novo Nordisk weight management drugs amid concerns of suicidal thoughts
NETHERLANDS — In response to reports of patients experiencing thoughts of suicide or self-injury, the European Medicines Agency (EMA) has launched an investigation into weight…
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EMA greenlights GSK’s Arexvy vaccine for respiratory syncytial virus (RSV) in adults
NETHERLANDS — The European Medicines Agency (EMA) has put GSK in a leading position in the respiratory syncytial virus (RSV) vaccine market, following its recent…