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Novartis secures first-of-a-kind haematology approval
A novel Factor B inhibitor of the immune system's complement pathway has been approved for paroxysmal nocturnal haemoglobinuria (PNH).
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First pill for desmoid tumours approved
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
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USP General Chapter <660>—Glass revised
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.
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FDA approves new therapy for myelodysplastic syndromes
The first targeted therapy for certain adults with the rare blood cancer myelodysplastic syndromes, has been approved by the US Food and Drug Administration (FDA).
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Regulatory-first for gene editing therapy
The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
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First-in-class phosphate absorption inhibitor approved by FDA
A first-in-class treatment with a differentiated mechanism of action has been approved to reduce serum phosphorus in chronic kidney disease (CKD) in individuals for which phosphate binders are not suitable.
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FDA issues draft guidance on alternative tools for facility assessments
As part of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
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Anti-PD-1 antibody gains EU approval for oesophageal cancer
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
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Paving the way for anti-Abeta active immunotherapy
Recent breakthroughs in anti-Abeta immunotherapy for Alzheimer's have shown disease-modifying potential, with vaccination emerging as a promising approach, as AC Immune’s Marija Vukicevic, Yves Kremer, Marie Kosco-Vilbois and Andrea Pfeifer explain.
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First treatment for myelofibrosis with anaemia approved
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
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FDA grants first approval for multiple sclerosis biosimilar
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
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Pfizer maternal RSV vaccine approved
The US Food and Drug Administration (FDA) has authorised an RSV vaccine for pregnant individuals, which in one study, reduced the risk of severe LRTD by 81.8 percent within 90 days after birth.
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CHMP to review MAA for geographic atrophy treatment
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
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Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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First oral medicine for postpartum depression approved
The first approved oral treatment that provides rapid symptomatic improvement in postpartum depression (PPD) is expected to be commercially available in the fourth quarter of 2023.
