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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Drug importation is dangerous and won’t lower prices

9 June 2022 - Federal and state governments continually insert themselves into the medical marketplace in an attempt to lower prescription ...

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PHARMAC joins ACT’s call for a medicines strategy

8 June 2022 - “It appears that everyone wants a dedicated Medicines Strategy apart from Andrew Little, who is too ...

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Lupin receives tentative approval from U.S. FDA for ivacaftor tablets

8 June 2022 - Lupin today announced that it has received tentative approval from the United States FDA for its ...

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U.S. FDA approves Foundation Medicine’s FoundationOne CDx as a companion diagnostic for Roche’s Rozlytrek (entrectinib)

9 June 2022 - This approval marks the first and only companion diagnostic indication for Rozlytrek, and another important milestone in ...

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AlgoTx’s ATX01 granted fast track designation by FDA for chemotherapy-induced neuropathic pain

9 June 2022 - AlgoTx announced today that it has received fast track designation from the U.S. FDA for the ...

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COVID-19 vaccine weekly safety report (9 June 2022)

9 June 2022 - To 5 June 2022, the TGA has received 577 reports which have been assessed as likely to ...

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The days of the independent republic of PHARMAC are far from over

9 June 2022 - When he announced the government’s response to the recent independent review of PHARMAC Health Minister Andrew Little ...

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Scynexis announces submission of supplemental new drug application of Brexafemme (ibrexafungerp tablets) to the U.S. FDA for an expanded indication for the prevention of recurrent vaginal yeast infection

8 June 2022 - Regulatory submission for the label extension is supported by positive data from the pivotal Phase 3 ...

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Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes

8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...

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European Commission approves Roche’s first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma

8 June 2022 - Approval is based on the phase I/II GO29781 study, where Lunsumio induced high complete response rates, with ...

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Health Canada approves Tabrecta: targeted cancer therapy for locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations

8 June 2022 - Newest treatment for lung cancer reinforces Novartis commitment to developing innovative therapies that improve outcomes for ...

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EMA adopts first list of critical medicines for COVID-19

8 June 2022 - On 7 June 2022, the EMA’s Medicines Shortages Steering Group adopted the list of critical medicines for ...

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TLV reconsiders subsidy of cyclin-dependent kinase 4/6 inhibitor Verzenios

8 June 2022 - Since April 2022, Verzenios has had market approval for the treatment of adult patients with early breast ...

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Irish parents ‘breaking down and crying’ as children denied life changing cystic fibrosis medication

8 June 2022 - Sarah O’Keeffe found out that her son would not be getting the medication that would improve his ...

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Allogene Therapeutics announces the FDA granted regenerative medicine advanced therapy designation to ALLO-501A for large B-cell Lymphoma

8 June 2022 - In the ALPHA trials with ALLO-501 and ALLO-501A, treatment was initiated approximately 2 days from enrollment, eliminating ...

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