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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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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Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy

11 May 2022 - NICE has published evidence based recommendations on the use of avelumab for adults with locally advanced ...

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ATAGI update following weekly COVID-19 meeting (4 May 2022)

9 May 2022 - On Wednesday 4 May 2022, ATAGI met to consider the latest developments relating to COVID-19 immunisation. ...

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Amicus Therapeutics receives notification of PDUFA date extensions for AT-GAA

10 May 2022 - Amicus Therapeutics today announced that the U.S. FDA has extended the review period by 90 days ...

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Remake of the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009

11 May 2022 - The Department has recently remade the National Health (Pharmaceutical and Vaccines—Cost Recovery) Regulations 2009 (2009 Regulations), ...

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