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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SMC accepts oral therapy for relapsing multiple sclerosis

10 November 2021 - Janssen has announced that the SMC have accepted Ponvory (ponesimod) within NHS Scotland, as a treatment for ...

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EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11

10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...

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Universal health care is a fundamental right — being delusional is not

10 November 2021 - Singapore’s Health Ministry has announced that its citizens who choose not to be vaccinated will be ...

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Health Canada authorises the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot

9 November 2021 - Health Canada has authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot. ...

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Moderna's COVID-19 vaccine (Spikevax) - provisional determination granted for proposed use in children and booster shot for adults under evaluation

10 November 2021 - The TGA has granted a provisional determination to Moderna in relation to its COVID-19 vaccine, Spikevax. ...

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Australia to wait for data from US children before clearing vaccine here

10 November 2021 - Australia’s top immunisation advisers will wait on safety data from at least several hundred thousand young ...

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WHO warns of massive syringe shortfall in 2022

10 November 2021 - There could be a shortage of up to two billion syringes in 2022 with billions more than ...

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Merck and Ridgeback announce U.S. Government to purchase 1.4 million additional courses of molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults

9 November 2021 - Merck and Ridgeback Biotherapeutics today announced that the United States Government will exercise two of its options ...

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ICER releases draft evidence report on tirzepatide for type 2 diabetes mellitus

9 November 2021 - Public comment period now open until 8 December 2021; requests to make oral comment during public ...

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FDA’s Woodcock says agency has resumed normal review pace for biosimilars, generics

9 November 2021 - Janet Woodcock, MD, acting commissioner of the FDA, delivered an upbeat report on biosimilars and generics progress ...

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Moderna files to expand the conditional marketing authorisation for its COVID-19 vaccine in the European Union to include children ages 6-11 years

9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...

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BerGenBio receives FDA fast track designation for bemcentinib in STK11 mutated advanced/metastatic non-small-cell lung cancer

9 November 2021 - BerGenBio today announces that the U.S. FDA has granted fast track designation for bemcentinib in combination with ...

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Plus Therapeutics receives FDA fast track designation for 186RNL targeted radiotherapeutic for leptomeningeal metastases

9 November 2021 -  Plus Therapeutics today announced that the U.S. FDA has granted the Company fast track designation for ...

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A toxic drug price deal

8 November 2021 - The latest version of government price controls is barely better than the first. ...

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TGA grants provisional determination to AstraZeneca for COVID-19 preventative treatment, tixagevimab and cilgavimab (Evusheld)

9 November 2021 - On 4 November 2021, the TGA granted provisional determination to AstraZeneca in relation to the COVID-19 treatment ...

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