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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Vertex announces U.S. FDA approval for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 12 to <24 months

2 September 2022 - With this approval, approximately 300 children with two copies of the F508del mutation will have a ...

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FDA approves durvalumab for locally advanced or metastatic biliary tract cancer

2 September 2022 - Today the FDA approved durvalumab (Imfinzi, AstraZeneca) in combination with gemcitabine and cisplatin for adult patients ...

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First de novo deuterated drug poised for approval

1 September 2022 - Bristol Myers Squibb’s first in class TYK2 inhibitor and blockbuster contender deucravacitinib showcases the role for heavy ...

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Azurity Pharmaceuticals announces FDA approval of Konvomep (omeprazole and sodium bicarbonate for oral suspension)

2 September 2022 - Azurity Pharmaceuticals announced today that the US FDA has approved Konvomep (omeprazole and sodium bicarbonate for oral ...

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FDA approves the first treatment option for generalized pustular psoriasis flares in adults

1 September 2022 - More than half of patients treated with Spevigo (spesolimab-sbzo) injection, for intravenous use showed no visible pustules ...

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Updated agenda for the November 2022 PBAC meeting

2 September 2022 - The agenda for the November 2022 PBAC meeting has been updated.  ...

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EMA CHMP adopts positive opinion recommending authorisation for the use of Moderna's Omicron targeting bivalent booster in the European Union

1 September 2022 - Study results show mRNA-1273.214 has demonstrated significantly higher antibody titers against Omicron BA.1 and BA.4/5 sub-variants when ...

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CADTH launches post-market drug evaluation program

1 September 2022 - CADTH is pleased to announce the launch of its new post-market drug evaluation program. ...

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Recell System insurance coverage begins in Japan for treatment of acute burns

1 September 2022 - Reimbursement in Japan will be similar to that of pricing in the United States. ...

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Health Canada authorises first bivalent COVID-19 booster for adults 18 years and older

1 September 2022 - Today, Health Canada authorised an adapted version of the Moderna Spikevax COVID-19 vaccine.  ...

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Vabysmo (faricimab injection) receives positive CADTH recommendation for the treatment of neovascular (wet) age-related macular degeneration in adults

1 September 2022 - Provincial jurisdictions will make the final decision on public reimbursement. ...

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What “negotiating” with Medicare means for drug makers: a mixture of price controls and actual negotiations

1 September 2022 - In the debate on the drug pricing provisions contained in the Inflation Reduction Act, critics call the ...

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First adapted COVID-19 booster vaccines recommended for approval in the EU

1 September 2022 - The EMA’s CHMP has recommended authorising two vaccines adapted to provide broader protection against COVID-19.  ...

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Critical kidney disease medication listed on the PBS

1 September 2022 - A life changing treatment for chronic kidney disease will be made available to thousands of Australians through ...

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Janssen's Stelara gets insurance benefits as first-line therapy for ulcerative colitis

1 September 2022 - Janssen Korea said its ulcerative colitis Stelara (ustekinumab) won health insurance benefits as the primary treatment ...

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