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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Galapagos announces US FDA regenerative medicine advanced therapy designation granted to GLPG5101 for the treatment of relapsed/refractory mantle cell lymphoma

6 August 2025 - Galapagos NV (Euronext & NASDAQ: GLPG) today announced that the United States Food and Drug Administration (FDA) ...

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The US FDA granted fast track designation to Dizal's birelentinib for relapsed/refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma

6 August 2025 - Supporting data from a pooled analysis of Phase I/II studies of birelentinib showed an objective response ...

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NICE approves first immunotherapy combination for endometrial cancer

6 August 2025 - Around 2,100 people with advanced womb cancer are set to benefit from a groundbreaking new treatment option, ...

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FDA grants accelerated approval to dordaviprone for diffuse midline glioma

6 August 2025 -Today, the FDA granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and ...

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Patients to receive medicines 3 to 6 months faster under 10 year health plan

 6 August 2025 - NICE and the MHRA have described how the 10 year health plan will lead to faster medicines ...

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How Australia is getting tangled in Trump’s fight with big pharma

6 August 2025 - The US president is angry Americans pay more for their medicines. Will he want the PBS – ...

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Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD

5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...

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Health technology assessment, again: a transparent, evidence-based approach for CMS drug price negotiations

4 August 2025 - The CMS can now negotiate the prices of a set of drugs that represent significant Medicare expenditures. ...

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Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) accepted for priority review by US FDA in fifth cancer type for relapsed or refractory marginal zone lymphoma

4 August 2025 - Bristol Myers Squibb today announced that the US FDA has accepted the supplemental biologics license application ...

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Clarametyx Biosciences announces FDA grant of fast track and qualified infectious disease product designations for CMTX-101

4 August 2025 - Clarametyx Biosciences today announced that the US FDA has granted fast track and qualified infectious disease ...

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Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-251 in Duchenne muscular dystrophy

4 August 2025 -  Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-251 for ...

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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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