FDA approves new antibiotic for three different uses

3 April 2024 - Today, the US FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with ...

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RemeGen's telitacicept (RC18) granted fast track designation by US FDA for treatment of primary Sjögren's syndrome

2 April 2024 - RemeGen has obtained fast track designation by the US FDA recently for its innovative BLyS/APRIL dual-target ...

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Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed

2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...

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Solid Biosciences receives rare paediatric disease designation from the FDA for Duchenne muscular dystrophy gene therapy candidate SGT-003

1 April 2024 - Site initiations scheduled for April; patient dosing expected to begin in Q2 ,2024. ...

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TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer

2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...

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Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer

2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...

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Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH

1 April 2024 - Approval of first in class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase ...

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Eisai completes submission of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA

1 April 2024 -  Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...

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US FDA accepts Astellas’ supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy

1 April 2024 - Target action date set for 19 November 2024. ...

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FDA Approves Medexus's supplemental biologics license application for Ixinity to treat haemophilia B in paediatric patients

26 March 2024 - Expanded indication includes patients under 12 years of age, based on Phase 3/4 data demonstrating safety and ...

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LISCure Biosciences receives US FDA fast track designation for LB-P8 for the treatment of primary sclerosing cholangitis

29 March 2024 - Phase 2 study is underway and LB-P8 is the only live biotherapeutic product currently reported to be ...

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Korean drug for metabolism-related steatohepatitis gets FDA’s fast track designation

28 March 2024 - D&D Pharmatech said Thursday that DD01, an injectable treatment for metabolic-associated steatohepatitis (MASH) being developed by ...

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IntraBio announces US FDA accepts new dug application for IB1001 for the treatment of Niemann-Pick disease type C

26 March 2024 - PDUFA date set for 24 September 2024. ...

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Akebia receives FDA approval of Vafseo (vadadustat) tablets for the treatment of anaemia due to chronic kidney disease in adult patients on dialysis

27 March 2024 - Once daily oral HIF-PH inhibitor activates physiologic response to manage anaemia. ...

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Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukaemia

26 March 2024 - PDUFA action date set for 26 September 2024. ...

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