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FDA green light for trial of allogeneic regulatory T cell therapy

Drug Discovery World

The US Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for Tr1X’s TRX103 for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched haematopoietic stem cell transplantation (HSCT). “As a result, innovative treatments are urgently needed.”

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FDA withdraws approval of Oncopeptides’ Pepaxto

Drug Discovery World

The US Food and Drug Administration (FDA) has announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), despite an appeal by manufacturer Oncopeptides. The FDA has now suspended enrolment in all ongoing Pepaxto clinical trials.

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FDA grants orphan drug and paediatric exclusivities for Cresemba

Drug Discovery World

The US Food and Drug Administration (FDA) has granted orphan drug and paediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in paediatric patients. Paediatric exclusivity extends that period by another six months. .”

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FDA advisory committee meeting delays approval of donanemab

Drug Discovery World

The US Food and Drug Administration (FDA) has revealed plans to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial. The post FDA advisory committee meeting delays approval of donanemab appeared first on Drug Discovery World (DDW).

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Minerva value plummets following FDA rejection of roluperidone

Drug Discovery World

The stock market value of Minerva Biosciences has dropped nearly 60%, following the US Food and Drug administration (FDA) decision not to approve roluperidone for symptoms of schizophrenia. The company received a ‘Complete Response Letter’ from the FDA highlighting the clinical deficiencies in its new drug application (NDA).

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FDA approves Covid-19 mAb for emergency use in immunocompromised

Drug Discovery World

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to half-life extended monoclonal antibody (mAb) Pemgarda (pemivibart, or VYD222) for the pre-exposure prophylaxis (prevention) of Covid-19.

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FDA approves new treatment option for anaemia due to kidney disease

Drug Discovery World

The US Food and Drug Administration (FDA) has approved Vafseo (vadadustat) Tablets for the treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.