FINOSE now covers all Nordic countries

18 April 2024 - Icelandic Landspitali joins the Nordic collaboration FINOSE, where HTA authorities from the Nordic countries carry out ...

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Merck’s superovulation induction drug Pergoveris gets expanded coverage

1 April 2024 - Merck Biopharma Korea's superovulation induction injection Pergoveris (follitropin alfa) will receive expanded reimbursement to treat patients ...

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PHARMAC publishes agenda for May 2024 PTAC meeting

28 March 2024 - Another slim agenda; one cancer medicine. ...

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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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Schedule of Pharmaceutical Benefits - 1 April 2024

1 April 2024 - The April 2024 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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New Zealand Pharmaceutical Schedule - 1 April 2024

1 April 2024 - The April 2024 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...

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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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Paladin Labs announces approval of Wakix (pitolisant hydrochloride tablets) for use in paediatric patients in Canada

28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...

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PTC announces submission of sepiapterin MAA for treatment of PKU to EMA

28 March 2024 - First marketing authorisation submission for sepiapterin with additional global submissions to follow in 2024. ...

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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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Abilify Maintena 960 mg (aripiprazole) approved in the EU as the first once every two months long-acting injectable for the maintenance treatment of schizophrenia

27 March 2024 - Otsuka Pharmaceutical announces that its subsidiary Otsuka Pharmaceutical Europe and Lundbeck announced that the European Commission ...

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China's National Medical Products Administration accepts Astellas and Pfizer's supplemental biologics license application for enfortumab vedotin with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer

28 March 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing ...

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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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