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 ...

Read more →

European Commission expands Jemperli (dostarlimab) plus chemotherapy approval to all adult patients with primary advanced or recurrent endometrial cancer

20 January 2025 - Expanded approval includes MMRp/MSS tumours, which represent approximately 75% of endometrial cancer cases. ...

Read more →

BIO statement on new list of medicines targeted for Government price setting

17 January 2025 - The Biotechnology Innovation Organization (BIO) today released the following statement after the Biden administration released a ...

Read more →

Australians benefit from freeze to maximum cost of PBS medicines

20 January 2025 - The Australian Government has launched an advertising campaign to raise awareness about a freeze on the maximum ...

Read more →

Handok's AML treatment Vyxeos receives insurance coverage in Korea

2 December 2024 - Handok said Monday that its acute myeloid leukaemia treatment, Vyxeos liposomal injection (cytosine arabinoside and daunorubicin ...

Read more →

Protection against RSV for mums and bubs with free vaccine available from 3 February

19 January 2025 - From 3 February 2025, Australian mums and their newborn babies will have free access to the best ...

Read more →

Human medicines in 2024

16 January 2025 - In 2024, EMA recommended 114 medicines for marketing authorisation.  ...

Read more →

Junshi Biosciences announces toripalimab’s approval in Australia

17 January 2025 - Shanghai Junshi Biosciences announced that toripalimab, the anti-PD-1 monoclonal antibody self-developed by the company, has obtained the ...

Read more →

Long wait for cancer drug approvals causing 'great anguish' among patients, doctors

18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...

Read more →

New EU rules for health technology assessments become effective

10 January 2025 - Enhanced EU collaboration to allow faster and wider access to innovative health technologies. ...

Read more →

Ozempic among the next drugs up for Medicare price negotiations

17 January 2025 - List of drugs account for $41 billion in annual Medicare spending, Biden administration says. ...

Read more →

Aprocitentan approved to treat adults with hypertension whose blood pressure cannot be controlled by other medications

17 January 2025 - The MHRA has approved the medicine aprocitentan (Jeraygo) to treat hypertension in adults whose blood pressure cannot ...

Read more →

US FDA approves FoundationOne CDx as a companion diagnostic for Ojemda (tovorafenib) to treat the most common form of childhood brain tumour in paediatric patients

17 January 2025 - The approval supports the identification of therapeutic options for patients with relapsed or refractory BRAF altered paediatric ...

Read more →

Illuccix receives European approval

17 January 2025 - Telix today announces that it has received a positive decision on the marketing authorisation application for ...

Read more →

Arrowhead Pharmaceuticals announces acceptance of new drug application by US FDA of plozasiran for the treatment of familial chylomicronaemia syndrome

17 January 2025 - The new drug application is based on positive results from the Phase 3 PALISADE study. ...

Read more →

Health Canada approves Otsuka and Lundbeck's Abilify Asimtufii (aripiprazole), the first and only, once every two months, long-acting injectable treatment for schizophrenia and for maintenance monotherapy of bipolar I disorder in adults

17 January 2025 - Otsuka Pharmaceutical Canada and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance ...

Read more →