FDA approves investigational new drug application for treatment of mucopolysaccharidosis type IIIA

Swedish Biopharmaceutical company, Swedish Orphan Biovitrum AB has announced that the FDA has issued a “study may proceed” letter for the first study in humans, thereby accepting the investigational new drug (IND) application for the drug candidate SOBI003 for the treatment of mucopolysaccharidosis type IIIA. In addition, SOBI003 was granted Fast Track status by the

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FDA give Novartis’ breast cancer treatment breakthrough status

Novartis’ CDK4/6 inhibitor Kisqali has acquired Breakthrough status in the US as an initial endocrine-based treatment in certain patients with breast cancer. The FDA awarded the designation for of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with tamoxifen or an aromatase

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Novo Nordisk gains approval for once per week diabetes drug by FDA

Novo Nordisk has acquired its first global approval for its once-weekly diabetes therapy Ozempic in the US. The FDA has approved the drug’s use alongside diet and exercise to improve glycaemic control in adults with type II diabetes. Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist that induced clinically meaningful and statistically significant reductions

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US FDA approval for Alexion’s Myasthenia Gravis Treatment, Soliris

Alexion has finally claimed FDA approval for its complement inhibitor Soliris in Myasthenia Gravis (MG), which could potentially add $1bn-plus in peak sales for the product. The US regulator has approved Soliris (Eculizumab) to treat adults with refractory generalised MG who are anti-acetylcholine receptor (AchR) antibody-positive, a patient group that “continues to suffer from significant

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FDA launches global operation with the aim of protecting consumers from potentially dangerous prescription drugs sold online

The FDA, in partnership with international regulatory and law enforcement agencies, recently acted against over 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines. Medicines which included opioids, antibiotics and injectable epinephrine products to American consumers. These actions were part of a major global operation that the FDA participated in to target

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