Minister announces parallel assessment means new medicines assessed sooner

28 February 2024 - PHARMAC is changing its process so it can assess a funding application at the same time Medsafe ...

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New treatment for rare motor neurone disease recommended for approval

23 February 2024 - The EMA has recommended granting a marketing authorisation in the European Union for a new therapy ...

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Shortage of migraine medication crushing for chronic pain patients

23 February 2024 - A migraine medication shortage has spread across the country, threatening to leave tens of thousands of ...

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FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide)

23 February 2024 - Today, the FDA announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was ...

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Bristol Myers Squibb receives positive CHMP opinion for Reblozyl (luspatercept) for treatment of adults with transfusion-dependent anaemia due to low- to intermediate-risk myelodysplastic syndromes

23 February 2024 - In the pivotal Phase 3 COMMANDS study, Reblozyl nearly doubled the percentage of patients achieving primary ...

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Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as neo-adjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence

23 February 2024 - Opinion granted based on positive overall survival and event-free survival results from the Phase 3 KEYNOTE-671 trial. ...

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Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of COPD with type 2 inflammation

23 February 2024 - Priority review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be ...

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Curium announces submission of the marketing authorisation application for Pylclari, an innovative (18F)-PSMA PET tracer indicated in adults with prostate cancer to Swissmedic

22 February 2024 - Curium announced today that the marketing authorisation application for Pylclari (piflufolastat (18F)) submitted by exclusive Swiss ...

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US FDA grants priority review to Harmony Biosciences' application for Wakix (pitolisant) in paediatric narcolepsy

21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024. ...

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Avidity Biosciences receives FDA rare paediatric disease designation for AOC 1044 for treatment of Duchenne muscular dystrophy in people with mutations amenable to exon 44 skipping

20 February 2024 - Avidity Biosciences today announced that the US FDA has granted rare paediatric disease designation to AOC 1044, ...

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Artiva Biotherapeutics receives FDA fast track designation for AlloNK in lupus nephritis

22 February 2024 - Artiva Biotherapeutics announced today that the US FDA has granted fast track designation to Artiva’s lead ...

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TGA approves new medication for treatment of endometriosis symptoms

23 February 2024 - Australian drug regulator gives company green light for tablet – although it won’t be subsidised by Pharmaceutical ...

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Insulin prices were capped for millions. But many still struggle to afford to life-saving medication.

21 February 2024 - Insulin prices recently decreased for some of the estimated 8.4 million Americans who rely on the ...

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Busy dad with leukaemia getting 'outdated treatment'

23 February 2024 - A West Coast dad is receiving “outdated treatment” for his leukaemia because PHARMAC’s policies are blocking ...

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A cancer doctor’s view of why reform of PHARMAC is vital

23 February 2024 - Late last year, many of my colleagues returned from the largest international gathering of doctors who ...

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Up to 14,000 people could benefit from the first treatment for severe alopecia recommended by NICE

22 February 2024 - Thousands of people with severe hair loss due to alopecia areata are set to benefit from a ...

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