The US drug watchdog has approved a world-first biannual HIV pre-exposure prophylaxis injection, and the manufacturer has already lodged a TGA application. Gilead’s HIV-1 capsid…
The US Food and Drug Administration has approved the first new drug for moderate to severe acute pain in 25 years. Called suzetrigine, the first-in-class…
Recombinant herpes zoster vaccine Shingrix carries a “very rare” risk of Guillain–Barre syndrome, the TGA says. The regulator says patients should be advised to seek…
The US medicines watchdog has recommended more frequent liver testing for patients taking the new non-hormonal menopause drug fezolinetant after an isolated but serious liver…
The long-acting monoclonal antibody nirsevimab may be more effective in protecting infants against respiratory syncytial virus than clinical trial results would suggest, according to a…
The incidence of secondary primary malignancy after anti-CD19 chimeric antigen receptor T-cell immunotherapy is very low, according to a study in Nature Medicine. US researchers…
This article has been updated. The US medicines regulator has slapped a boxed warning on the osteoporosis medication denosumab regarding the increased risk of severe…
The TGA has approved the first respiratory syncytial virus vaccine, Arexvy, with sponsor GSK Australia hinting it would “soon” be available on a private script…
The worldwide semaglutide shortage has sparked an ’emerging trend’ of telehealth platforms offering to prescribe locally compounded versions of the drug to treat obesity, the…
The TGA is closely watching an overseas investigation of chimeric antigen receptor T-cell therapies after reports of secondary malignancies in treated patients. Last month, the…
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