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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Agenda for the March 2026 PBAC meeting (4 March 2026)

6 March 2026 - The Department of Health has published an updated agenda for the March 2026 PBAC agenda (version ...

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HLS Therapeutics announces Nilemdo (bempedoic acid) is now available in Canada for the reduction of LDL-cholesterol in patients at risk of cardiovascular disease

5 March 2026 - HLS Therapeutics today announced the commercial launch of Nilemdo (bempedoic acid) in Canada. Nilemdo is now available ...

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Roche's Columvi, Takeda's Fruzaqla pass first review for Korea insurance coverage

5 March 2026 - Roche's DLBCL treatment Columvi (glofitamab) and Takeda's metastatic colorectal cancer treatment Fruzaqla (fruquintinib) have cleared the ...

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FDA approves teclistamab in combination with daratumumab hyaluronidase-fihj for relapsed or refractory multiple myeloma

5 March 2026 - Today, the FDA approved teclistamab (Tecvayli, Janssen Biotech) in combination with daratumumab hyaluronidase-fihj for adult patients ...

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New multi-indication PBS listing for two immunotherapy treatments from March 2026

1 March 2026 - Bristol Myers Squibb Australia confirms that Opdivo (nivolumab) and Yervoy (ipilimumab) will be listed on the ...

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Hemab Therapeutics receives FDA breakthrough therapy designation for sutacimig in Glanzmann thrombasthenia

5 March 2026 - Sutacimig has potential to become a first in class prophylactic treatment for Glanzmann thrombasthenia, an inherited serious ...

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PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026

4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...

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Dying father pleads for cancer drug subsidy to ‘keep being a dad’

5 March 2026 - A North Queensland mother has travelled to Canberra to beg the Federal Government to save her ...

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Priovant announces FDA acceptance and priority review of new drug application for brepocitinib in dermatomyositis

3 March 2026 - Priovant Therapeutics today announced that the US FDA has accepted its new drug application for brepocitinib for ...

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New proposal aims to reduce complications following a stem cell transplant

5 March 2026 - People who have just had a stem cell transplant could be better protected from a serious ...

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Affinia Therapeutics granted FDA fast track designation for AFTX-201 as a treatment for people living with BAG3-associated dilated cardiomyopathy

4 March 2026 - Affinia Therapeutics today announced that the US FDA has granted fast track designation for AFTX-201, a potential ...

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Problems in study implementation: It often affects patient reported outcomes.

2 March 2026 - Patient-reported outcomes are of great importance for the evaluation of new drugs. However, these outcomes are repeatedly ...

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Boryung adds Xpovio to blood cancer portfolio under Antengene license deal

4 March 2026 - Boryung said Wednesday that it has signed a license in deal with Antengene, a Chinese pharmaceutical ...

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J&J Korea receives reimbursement for Balversa in urothelial carcinoma

3 March 2026 - Johnson & Johnson Innovative Medicine Korea said it received reimbursement for Balversa (erdafitinib), a treatment for ...

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SpliSense granted EMA EARLY PRIME designation for SPL84 in cystic fibrosis

3 March 2026 - SpliSense today announced that the EMA has granted early Priority Medicines (e-PRIME) designation to SPL84 for ...

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