An explosion of digital mental health tools being offered for sale has presented regulators with a problem – how should they be classified and assessed for safety or efficacy?
Digital health company Better Therapeutics has submitted its lead prescription digital therapeutic (DTx) BT-001 to the FDA, seeking approval for use by adults with type 2 diabetes (T2D).
GSK is paying $66 million upfront to license rights to Spero Therapeutics novel antibiotic tebipenem Hbr, unswayed by the FDA's decision earlier this year not to approve the drug for adults
The competition authorities in Switzerland said this morning they have carried out a raid on a pharma company – now confirmed to be Novartis – as part of an investigation into a "possible u
GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug
The EU has blocked the merger of Illumina and Grail, saying the deal would stifle innovation in blood-based diagnostics for cancer diagnostics, just days after a bid by the US authorities t
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.