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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A novel Factor B inhibitor of the immune system's complement pathway has been approved for paroxysmal nocturnal haemoglobinuria (PNH).
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
To create opportunity for glass innovation, the Packaging and Distribution Expert Committee (PD EC) revised the United States Pharmacopeia (USP) General Chapter —Glass.
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).
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.
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.
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Biosimilar User Fee Act (BsUFA) reauthorisation negotiations, the US Food and Drug Administration (FDA) has issued new draft guidance on alternative tools for assessing drug manufacturing facilities.
Approval of BeiGene’s TEVIMBRA® (tislelizumab) in EU follows an agreement with Novartis to regain global rights of the antibody treatment.
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.
The US Food and Drug Administration (FDA) has granted approval of a treatment for anaemic patients with a rare blood cancer.
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.
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.
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.
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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.