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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Gilead’s Trodelvy wins Korean coverage for breast cancer -- too late for some and still off-limits up front

12 June 2025 - It took two years, 100,000 signatures, and a wave of public pressure from patients and doctors. ...

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Health Canada authorises PiaSky (crovalimab for injection) as the first monthly (every four weeks) subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria

11 June 2025 - Roche Canada is pleased to announce that Health Canada has authorised PiaSky (crovalimab for injection) as ...

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Oxford vaccine against deadly Nipah virus granted EMA PRIME designation

11 June 2025 - The University of Oxford’s vaccine to protect people from deadly Nipah virus has been granted support from ...

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Radiopharm Theranostics granted US FDA fast track designation for RAD101 imaging in brain metastases

11 June 2025 - Radiopharm Theranostics today announced that the US FDA has granted fast track designation for RAD101 to ...

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Cantargia’s nadunolimab antibody awarded US FDA fast track designation

11 June 2025 - Cantargia today announced that the US FDA has granted fast track designation to nadunolimab, Cantargia's anti-IL1RAP antibody ...

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FDA approves taletrectinib for ROS1 positive non-small cell lung cancer

11 June 2025 - Today, the FDA approved taletrectinib (Ibtrozi, Nuvation Bio), a kinase inhibitor, for adults with locally advanced ...

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US FDA approves expanded indication for AbbVie's Mavyret (glecaprevir/pibrentasvir) as first and only treatment for people with acute hepatitis C virus

11 June 2025 -  AbbVie today announced that the US FDA approved a label expansion for Mavyret (glecaprevir/pibrentasvir), an oral ...

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Priorities for a new FDA

10 June 2025 - Why does it take more than 10 years for a new drug to come to market? Why ...

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Calls for weight loss drugs like Ozempic to be subsidised for people with schizophrenia

11 June 2025 - Queensland researchers are calling for weight loss medicines to be listed on the PBS for people ...

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Azurity Pharmaceuticals announces the FDA approval of Xifyrm (meloxicam injection) for the management of moderate to severe pain in adults

10 June 2025 - Azurity Pharmaceuticals today announced that the US FDA has approved Xifyrm (meloxicam injection), an intravenous non-steroidal ...

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SNT-5505 awarded US FDA fast track designation

10 June 2025 - Syntara today announces that its lead candidate, SNT-5505, has been granted fast track designation by the ...

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Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination granted US FDA priority review for first-line maintenance treatment of extensive-stage small cell lung cancer

10 June 2025 - Target action (PDUFA) date set for 7 October 2025. ...

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X4 Pharmaceuticals granted fast track designation for mavorixafor for the treatment of chronic neutropenia by US FDA

10 June 2025 - X4 Pharmaceuticals today announced that the US FDA has granted fast track designation to mavorixafor, an oral ...

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Research funding and more treatment options to support the fight against MND

9 June 2025 - The Australian Government is providing a further $4.5 million and listing another treatment to ensure the ...

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DoH publishes revised agenda for July 2025 PBAC meeting (version 4)

10 June 2025 - The DoH has published a revised agenda for next month's PBAC meeting. ...

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