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 approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) topical gel for the treatment of acne vulgaris in patients twelve years of age and older

20 October 2023 - First and only FDA approved fixed dose, triple combination topical treatment. ...

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Zydus receives US FDA approval for Zituvio to treat adult patients with type 2 diabetes mellitus

20 October 2023 - The company received final approval from the US FDA for its new drug application for Zituvio ...

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1 November 2023 changes to the PBS listings of medicines for children and adolescents with chronic plaque psoriasis

23 October 2023 - On 1 November 2023, changes will be made to the authority requirements of the PBS listing ...

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End of COVID-19 emergency response

20 October 2023 - A statement from Australia's Chief Medical Officer, Professor Paul Kelly, on the end of the COVID-19 emergency ...

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We need a public option for pharmaceuticals

20 October 2023 - America is currently facing dual public health crises of record drug shortages and skyrocketing prices.  ...

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Should insurance cover Wegovy, Ozempic and other new weight loss drugs?

16 October 2023 - Insurance plans could cover blockbuster weight-loss medications such as Wegovy and Ozempic, but the benefits may not ...

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US Food and Drug Administration approves BioMarin's Voxzogo (vosoritide) for children under 5 years with achondroplasia

20 October 2023 - Expanded indication in the US now includes children of all ages with achondroplasia. ...

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Rezolute receives Priority Medicines (PRIME) eligibility from EMA for enhanced regulatory support of RZ358 in congenital hyperinsulinism

17 October 2023 - PRIME eligibility granted based on key positive data from the Phase 2B (RIZE) study and current ...

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Brukinsa receives positive recommendation from NICE in the UK for adult patients with chronic lymphocytic leukaemia

20 October 2023 - BeiGene today announced that NICE of the United Kingdom has issued a final draft guidance recommending ...

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FDA approves Penbraya, the first and only vaccine for the prevention of the five most common serogroups causing meningococcal disease in adolescents

20 October 2023 - The FDA’s decision is based on data from Phase 2 and Phase 3 trials, which demonstrated that ...

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FDA expands paediatric indication for entrectinib and approves new pellet formulation

20 October 2023 - Today, the FDA granted accelerated approval to entrectinib (Rozlytrek, Genentech) for paediatric patients older than 1 ...

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Ethical and legal considerations in social media research for health technology assessment: conclusions from a scoping review

20 October 2023 - The objective was to identify and describe the published guidance and current academic discourse of ethical issues ...

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Regeneron and Sanofi provide update on Dupixent (dupilumab) sBLA for chronic spontaneous urticaria

20 October 2023 - Regeneron Pharmaceuticals and Sanofi today announced that the US FDA has issued a complete response letter for ...

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Pfizer to price Covid drug Paxlovid at $1,390 per course

18 October 2023 - Health insurance plans will likely pay much less than the nearly $1,400 list price for Paxlovid, ...

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Sumitomo Pharma and Pfizer in Canada receive Health Canada approval for Myfembree

19 October 2023 - Sumitomo Pharma Canada and Pfizer Canada today announced that Health Canada has granted a notice of compliance ...

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