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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NHS patients missing out on new medicines that could extend lives

13 May 2022 - Data shows that 1.2 million additional NHS patients are currently eligible for vital medicines but are ...

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Women with moderate to severe fibroids set to be offered new one a day treatment following final draft guidance from NICE

13 May 2022 - Around 4,500 women with uterine fibroids will be eligible for a new oral treatment after NICE recommended ...

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TGA commences evaluation of Moderna COVID-19 vaccine (Spikevax) for children aged 6 months to 5 years old

13 May 2022 - The TGA has received, and immediately commenced evaluation of, an application from Moderna to extend the ...

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Update on U.S. FDA review of biologics license application for bimekizumab

13 May 2022 - UCB announced today that the U.S. FDA has issued a complete response letter regarding the biologics ...

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TGA removes age limit for BBIBP-CorV (Sinopharm) COVID-19 vaccine recognition for international travel to Australia

13 May 2022 - The TGA has determined that the BBIBP-CorV (Sinopharm) COVID-19 vaccine will be 'recognised' for all ages for ...

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CADTH expands scientific advice program to include advice on real world evidence

28 April 2022 - CADTH is expanding its scientific advice program to include applications for advice on real world evidence generation ...

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Basket trials: review of current practice and innovations for future trials

10 May 2022 - Basket trials, one type of master protocol, emerged as a tool for evaluating biomarker-targeted therapies among multiple ...

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Federal investigators find Medicare Advantage plans too often deny, delay needed care

10 May 2022 - Medicare Advantage plans that provide health insurance coverage to millions of US seniors deny some medically ...

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ATAGI update following weekly COVID-19 meeting (11 May 2022)

12 May 2022 - On Wednesday 11 May 2022, ATAGI met to consider the latest developments relating to COVID-19 immunisation. ...

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FDA approves oral formulation of treatment for amyotrophic lateral sclerosis

12 May 2022 - Today, FDA approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis.  ...

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Moderna completes FDA submission for use of COVID shot in adolescents, kids

11 May 2022 - Moderna has made all necessary submissions required by the U.S. FDA for emergency use authorisation of ...

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After a 5 year fight to lower drug prices, Ottawa's pledge quietly falls apart

12 May 2022 - What began with a promise to protect Canadians ended with a commitment to support pharmaceutical companies. ...

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FDA grants breakthrough device designation to Remedee Labs for its groundbreaking endorphin stimulation solution for the management of fibromyalgia

12 May 2022 - On World Fibromyalgia Awareness Day (May 12), the French startup Remedee Labs is announcing that the FDA ...

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Wysa receives FDA breakthrough device designation for AI led mental health conversational agent

12 May 2022 - New peer-reviewed studies demonstrate efficacy in managing chronic pain, depression and anxiety ...

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COVID-19 vaccine weekly safety report (12 May 2022)

12 May 2022 - To 8 May 2022, the TGA has received 554 reports which have been assessed as likely to ...

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