FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Voydeya (danicopan) granted first ever regulatory approval in Japan for adults with PNH to be used in combination with C5 inhibitor therapy

19 January 2024 - Approval of first in class, oral, factor D inhibitor based on ALPHA Phase 3 trial in ...

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US FDA grants mesoblast rare paediatric disease designation for Revascor (Rexlemestrocel-L) in children with congenital heart disease

19 January 2024 - Revascor increases size of left heart chamber and improves surgical outcomes in children with hypoplastic left ...

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Verastem Oncology granted fast track designation for combination of avutometinib and sotorasib for the treatment of KRAS G12C mutant non-small-cell lung cancer

18 January 2024 - On-going RAMP 203 trial assessing a more complete vertical blockade with RAF/MEK and KRAS G12C inhibition along ...

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UtilityTherapeutics announces FDA acceptance of PIVYA new drug application with priority review

17 January 2024 - Utility has received a Prescription Drug User Fee Act target action date of 24 April 2024. ...

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UCB announces MHRA approval for UCB’s Zilbrysq

18 January 2024 - Green light concerns generalised myasthenia gravis therapy ...

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Drug makers raise prices of Ozempic, Mounjaro and hundreds of other drugs

18 January 2024 - Companies hiked prices of 775 brand name drugs at start of new year. ...

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New orphan drug for a sub-type of acute myeloid leukaemia: G-BA sees significant additional benefit

18 January 2024 - Since July 2023, there has been one in Germany for patients who suffer from acute myeloid leukaemia ...

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US FDA declines to approve Shin Nippon Biomedical's migraine drug

17 January 2024 - The US health regulator has declined to approve Japan-based Shin Nippon Biomedical Laboratories' treatment for acute ...

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Updates to the HTA Policy and Methods Review Reference Committee (18 January 2024)

18 January 2024 - Communiques for three HTA Review Reference Committee meetings held in December 2023 are now available. ...

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Sudbury, Ontario family finally gets coverage for drug to treat daughter's rare epilepsy

16 January 2024 - Fenfluramine costs more than $3,000 a month and is not approved by Health Canada. ...

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Health Canada approves Uplinza (inebilizumab) for the treatment of neuromyelitis optica spectrum disorders

16 January 2024 - First and only anti-CD19 B-cell-depleting monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders ...

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Launch and post-launch prices of injectable cancer drugs in the US: clinical benefit, innovation, epidemiology and competition

17 January 2024 - We aimed to identify and quantify factors associated with launch prices and post-launch price changes of ...

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Prescription Drug Affordability Act aims to set limits on high medication prices

17 January 2024 - Lawmakers in Springfield are focusing on high prescription drug prices. ...

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Dupixent (dupilumab) US label updated with data further supporting use in atopic dermatitis with moderate to severe hand and foot involvement

16 January 2024 - Data included from first and only Phase 3 trial specifically evaluating a biologic in this difficult to ...

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PBAC - 2023 in review

18 January 2024 - In contrast to New Zealand, 2023 saw many new medicines listed on the PBS. ...

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