An alternative to opioids? Optimism over new ‘non-addictive’ analgesic
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…
Tag: FDA
‘Very rare’ risk of Guillain–Barre syndrome after Shingrix vaccination: TGA
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…
Warning over menopause drug and ‘rare but serious’ liver injury risk
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…
Infant RSV immunisation ‘highly effective’, real-world study confirms
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…
Secondary primary malignancies ‘rare’ after CAR T-cell immunotherapy
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…
Severe hypocalcaemia warning with osteoporosis drug
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…
TGA approves RSV vax for Australians over 60
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…
GP clinic’s compounded semaglutide scripts raise TGA alarm
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…
FDA investigates secondary malignancy risk with CAR T-cell therapy
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…
Popular decongestant ‘no better than placebo’, says FDA panel
Oral phenylephrine, a nasal decongestant in dozens of OTC cold and flu medications, is no better than placebo and could be struck off therapeutic goods…
