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 accepts filing of abbreviated new drug application and grants priority review for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose

10 June 2021 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...

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Core patient reported outcomes in cancer clinical trials

9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...

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Yuhan's Leclaza to be cheaper than AstraZeneca's Tagrisso

10 June 2021 - The price of Yuhan's third generation epidermal growth factor receptor tyrosine kinase inhibitor for treating patients ...

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Astellas’ Xtandi bags NICE approval in prostate cancer

10 June 2021 - Astellas’ oral treatment Xtandi has received approval from NICE for the treatment of metastatic hormone-sensitive prostate ...

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NICE recommends several treatment options to help thousands with moderate rheumatoid arthritis

10 June 2021 - Around 25,000 people with moderate rheumatoid arthritis that has not responded to conventional therapies are set to ...

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COVID-19 vaccine weekly safety report (10 June 2021)

10 June 2021 - Seven additional cases of blood clots with low blood platelets have been assessed as thrombosis with ...

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ATAGI update following weekly COVID-19 meeting – 9 June 2021

10 June 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 9 June ...

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Adamis provides update on Zimhi

9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...

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CyMedica Orthopedics announces FDA clearance for IntelliHab, a novel drug free, non-invasive modality for treatment of knee osteoarthritis pain

9 June 2021 - CyMedica Orthopedics today announced the U.S. FDA has cleared the submission of its latest technology for ...

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Copiktra (duvelisib) receives European Union marketing authorisation for the treatment of relapsed or refractory CLL and refractory FL

9 June 2021 - Secura Bio today announced that on 19 May 2021, the European Medicines Agency granted marketing authorisation for ...

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Two members of U.S. FDA advisory panel resign over Alzheimer's drug approval

9 June 2021 - Two members of a panel of outside advisors to the U.S. FDA have resigned in protest ...

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Integrating early economic evaluation into target product profile development for medical tests: advantages and potential applications

7 June 2021 - Target product profiles outline the characteristics that new health care technologies require to address an unmet clinical ...

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Stop blaming PHARMAC - we'd be worse off without it

10 June 2021 - Penny Tucker is concerned that there are “miracle drugs and biologics that have transformed many conditions ...

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Paladin Labs announces approval of Wakix (pitolisant) in Canada

9 June 2021 - Paladin Labs today announced Health Canada's approval of Wakix (pitolisant) for the treatment of excessive daytime sleepiness ...

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End ‘vaccine frustration’ and let pharmacies join the rollout: Pharmacy Guild

9 June 2021 - New South Wales, Victoria and Western Australia could all soon join Queensland in allowing rural or ...

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