AstraZeneca and Daiichi Sankyo’s Enhertu could become the first therapy approved by the FDA for use in any HER2-positive cancer, regardless of its location in the body.
The EMA’s human medicines committee refused marketing approvals for two drugs from Neuraxpharm and Apellis at its January meeting, but both companies have said they will a
Eisai and Biogen’s marketing application for Alzheimer’s disease therapy Leqembi will face an independent advisory committee convened by the EMA before a decision is made
Manufacturing problems have scuppered Astellas’ chances of approval in the US this month for zolbetuximab, currently leading the field among Claudin 18.2-targeted drug can
Digital health company Click Therapeutics has won an FDA breakthrough device designation for CT-155, a digital therapeutic (DTx) for the negative symptoms of schizophrenia
The UK medicines regulator has launched its mutual recognition framework for authorising medicines in a move that it says will help to bring new drugs to patients in the U
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.