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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FDA expands eligibility for Pfizer-BioNTech COVID-19 booster dose to 16 and 17 year olds

9 December 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 Vaccine, authorising the use ...

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Nivolumab for the adjuvant treatment of oesophageal carcinoma: indication of minor added benefit

1 December 2021 - Those affected develop fewer relapses than if they wait and see.  ...

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Consensus lacking on ‘value’ for new anti-cancer drugs

8 December 2021 - The high price tag of new anticancer drugs has fuelled debate about the value of these treatments, ...

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Heron Therapeutics announces FDA approval of a significant indication expansion for Zynrelef

9 December 2021 - Approval provides a significantly broader indication for Zynrelef, now covering approximately 7 million procedures a year. ...

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Canada's national strategy for drugs for rare diseases needs a holistic approach

8 December 2021 - International report summarises drugs for rare disease best practices and recommendations. ...

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Upadacitinib in atopic dermatitis: additional benefit for adults at high dose

1 December 2021 - Women should expect more serious adverse effects than men.  ...

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NICE publish final guidance recommending Aspaveli in adults with ultra rare blood disorder

9 December 2021 - The medicine is additionally undergoing assessment with the Medicines and Healthcare products Regulatory Agency for a ...

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COVID-19 vaccine weekly safety report (9 December 2021)

9 December 2021 - To 5 December 2021, the TGA has received 389 reports which have been assessed as likely to ...

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FDA authorises new long-acting monoclonal antibodies for pre-exposure prevention of COVID-19 in certain individuals

8 December 2021 - Today, the U.S. FDA issued an emergency use authorization for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and ...

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Don’t destroy future drug development

8 December 2021 - With support faltering for the massive big-government blowout Congress is trying to jam through by Christmas, ...

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FoundationOne CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma

8 December 2021 - Foundation Medicine’s tissue-based test is the first and only comprehensive genomic profiling test to be approved as ...

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PhRMA statement on White House drug pricing event

6 December 2021 - Pharmaceutical Research and Manufacturers of America President and CEO Stephen J. Ubl released the following statement ...

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FDA takes new steps aimed at advancing development of individualised medicines to treat genetic diseases

7 December 2021 - Today, the FDA is issuing a draft guidance to provide recommendations for managing the administration of individualised ...

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Funding Keytruda for melanoma but not for lung cancer is racist, health advocates say

8 December 2021 - PHARMAC has been accused of institutional racism and breaching the Treaty of Waitangi for funding drugs ...

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$56K Alzheimer’s drug avoiding Biden’s cost curbs, for now

8 December 2021 - A new $56,000 a year Alzheimer’s medication that’s leading to one of the biggest increases ever in ...

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