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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Review of the National Medicines Policy

11 October 2021 - The call for submissions closed on Friday 8 October 2021 and a total of 107 submissions have ...

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PHARMAC negotiates deal for molnupiravir to treat COVID-19

11 October 2021 - PHARMAC has negotiated an agreement with supplier MSD to purchase the antiviral molnupiravir.  ...

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70 percent of Kiwis want Government to give PHARMAC more money - survey

10 October 2021 - New Zealanders have sent a clear message to the Government to fund medicines better or their ...

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Brii Bio initiates submission of emergency use authorisation filing to U.S. FDA for BRII-196/BRII-198, its monoclonal antibody combination therapy for non-hospitalised COVID-19 patients at high risk of clinical progression to severe disease

8 October 2021 - Data supporting the EUA filing will be submitted to the FDA on a rolling basis with the ...

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New FDA chief can't come soon enough for beleaguered agency

8 October 2021 - One of the leading agencies in the government’s fight against COVID-19 is finally on the verge of ...

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Alpha Tau receives FDA's breakthrough device designation for the treatment of recurrent glioblastoma multiforme

8 October 2021 - Alpha Tau Medical is pleased to announce that it has received breakthrough device designation for Alpha ...

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Egetis Therapeutics receives FDA fast track designation for Emcitate for MCT8 deficiency

8 October 2021 - Egetis Therapeutics today announced that the U.S. FDA has granted the company’s lead candidate drug Emcitate, currently ...

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FDA approves innovative treatment for paediatric patients with congenital athymia

8 October 2021 - Today, the U.S. FDA approved Rethymic for the treatment of paediatric patients with congenital athymia, a rare ...

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Janssen submits application seeking U.S. FDA approval of Stelara (ustekinumab) for the treatment of paediatric patients with juvenile psoriatic arthritis

8 October 2021 - Application utilises extrapolation-based strategy across existing breadth of Stelara data in patients living with this chronic inflammatory ...

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Genentech’s anti-amyloid beta antibody gantenerumab granted FDA breakthrough therapy designation in Alzheimer’s disease

8 October 2021 - Gantenerumab is an investigational antibody in Phase 3 development for early Alzheimer's disease. ...

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ChemoCentryx announces FDA approval of Tavneos (avacopan) in ANCA associated vasculitis

8 October 2021 - First FDA approved orally administered inhibitor of the complement 5a receptor. ...

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Docs ‘use rubber stamp for drugs’

9 October 2021 - Pharmacists have raised the alarm over the influence of a US pharmaceutical corporation on Australian doctors ...

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Booster shot for severely immunocompromised Australians

8 October 2021 - From next week Australians who are severely immunocompromised will be offered the option to receive a third ...

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Recursion is granted FDA fast track designation for REC-2282 for the potential treatment of NF2 mutated meningiomas

7 October 2021 - Recursion today announced that the U.S. FDA has granted the company fast track designation for the ...

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Health Canada approves the use of Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis

7 October 2021 - Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials ...

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