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FDA grants Fast Track designation to prostate cancer treatment

Drug Discovery World

Biopharmaceutical company Syncromune has had its lead-candidate for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) granted Fast Track designation by the FDA. Reece Armstrong, Editor, DDW The post FDA grants Fast Track designation to prostate cancer treatment appeared first on Drug Discovery World (DDW).

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FDA expands gene therapy use in Duchenne muscular dystrophy

Drug Discovery World

The US Food and Drug Administration (FDA) has expanded its approval for Elevidys (delandistrogene moxeparvovec-rokl) to include individuals with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who are at least four years of age. The FDA granted accelerated approval for non-ambulatory patients.

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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 fast tracks Amolyt’s hypoparathyroidism therapy  

Drug Discovery World

Food and Drug Administration (FDA). Building upon findings from our successful Phase II 2 clinical trial, we are working diligently to execute our ongoing Calypso Phase III 3 study and look forward to topline data in 2025.” The post FDA fast tracks Amolyt’s hypoparathyroidism therapy appeared first on Drug Discovery World (DDW).

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FDA investigates safety of CAR-T cell immunotherapies

Drug Discovery World

The Food and Drug Administration (FDA) said it will investigate the safety of BCMA- or CD19-directed autologous CAR-T cell immunotherapies, following reports of T cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in these patients.

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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 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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