New cystic fibrosis drug fast tracked for NHS use

15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...

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Update from the PBAC (July 2025)

4 August 2025 - The PBAC update following the July 2025 PBAC meeting is now available. ...

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Why drug prices for some big medicines will remain high for a longer time

3 August 2025 - Little known provisions in the Big Beautiful Bill lobbied by industry will cost Medicare billions in missed ...

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PBS listing of Parkinson's drug a life-changing move for father of two Craig Gillespie

4 August 2025 - The price of a revolutionary treatment has plummeted from $130,000 a year to just $31.60 a script, ...

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Australians now take drastic steps to pay for vital medicines not on the PBS

4 August 2025 - Many Australians struggling to pay bills have had to borrow money, fundraise or take on extra work ...

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PHARMAC expands access to meningococcal B vaccine for children under 5

31 July 2025 - PHARMAC is extending access to the meningococcal B vaccine (Bexsero), with up to 77,000 more children ...

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Update on US regulatory review of supplemental biologics license application

1 August 2025 - The US FDA issued a complete response letter for the supplemental biologics license application for Darzalex ...

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Seladelpar lysine dihydrate for the treatment of patients with primary biliary cholangitis

30 July 2025 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...

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FDA approves Alhemo as once daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes for adults and children 12 years of age and older with haemophilia A or B without inhibitors

31 July 2025 - FDA approval is based on phase 3 trial data (explorer8), which established the safety and efficacy of ...

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Serplulimab in combination with carboplatin and etoposide phosphate for the first-line treatment of patients with extensive-stage small-cell lung cancer

30 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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BeOne Medicines receives PRIME designation from the EMA for BGB-16673 in Waldenström’s macroglobulinaemia

31 July 2025 - Decision highlights the promise of BGB-16673, an investigational and potentially first in class BTK degrader designed ...

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Reimbursement for oral Fabry disease drug Galafold expanded to first-line treatment

1 August 2025 - Handok's Fabry disease treatment, Galafold (migalastat), will have its insurance coverage criteria expanded to include first-line ...

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Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease

24 July 2025 - PDUFA target action date of 10 January 2026. ...

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Lenz Therapeutics announces US FDA approval of Vizz for the treatment of presbyopia

31 July 2025 - Vizz samples and product availability in the US expected as early as October 2025. ...

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Norgine welcomes PBS listing in Australia of Ifinwil (eflornithine) for patients with high-risk neuroblastoma

1 August 2025 - Approximately 50 children in Australia are diagnosed with neuroblastoma each year, with nearly half classified as having ...

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Trump takes aim at ‘foreign freeloading nations’ over drug prices in new threat to PBS

1 August 2025 - US President Donald Trump has blamed “foreign freeloading nations” for the high drug prices faced by ...

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