The FDA has approved the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu for all HER2-positive solid tumours, in a first for both HER2 inhibitors a
Johnson & Johnson and Legend Biotech’s BCMA-targeted CAR-T therapy Carvykti has been approved by the FDA to treat patients with multiple myeloma after at least one pri
Basilea Pharmaceutica will finally be able to bring its antibiotic ceftobiprole to the US market, around 15 years after the drug was first turned down by the FDA.
The FDA has cleared an artificial intelligence algorithm that can detect signs of heart failure in seconds using a digital stethoscope during a standard physical exam.
Otsuka and Click Therapeutics’ Rejoyn has become the first prescription digital therapeutic (DTx) to be approved by the FDA for people with major depressive disorder.
AstraZeneca’s Voydeya has become the first oral Factor D inhibitor to be approved by the FDA as a treatment for the rare disease paroxysmal nocturnal haemoglobinuria (PNH)
Owlstone Medical has secured a $5 million equity investment and initial $1.5 million grant funding, committed by the Bill and Melinda Gates Foundation, for development of
It’s 2024, and in most clinical trials, data is still being moved from the EHR to the EDC manually – with employees reading data from one screen and typing it onto another.