Iovance Biotherapeutics is facing a three-month delay in the review of its lifileucel cell therapy for melanoma in the US, held up by "insufficient resources" at the FDA.<
The financial regulator in the US has warned the pharma industry that it may consider legal action against companies that improperly list patents in the FDA's 'Orange Book
Despite a sceptical appraisal by FDA reviewers, Alnylam's Onpattro has been recommended for approval as a treatment for transthyretin amyloidosis cardiomyopathy (ATTR-CM)
An FDA advisory committee has concluded that a commonly used decongestant ingredient used in cold and allergy products does not have any efficacy, raising the possibility
AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is.
The FDA has published its first-ever guidance document on clinical trials with psychedelic drugs, an emerging treatment category for psychiatric and substance use disorder
Cancer Research UK (CRUK) has said it will award £123 million ($150 million) in funding over the next seven years to Scotland’s Beatson Institute, which will be renamed th
To improve trial recruitment, engagement, and retention, and to increase the likelihood that trials reflect what matters most to patients, regulatory authorities increasingly point to metho