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.
Despite a sceptical appraisal by FDA reviewers, Alnylam's Onpattro has been recommended for approval as a treatment for transthyretin amyloidosis cardiomyopathy (ATTR-CM)
The EMA will kick off a review of Astellas and Pfizer's prostate cancer therapy Xtandi in an earlier-stage form of the cancer, which if approved could give the product a l
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.
Italfarmaco's marketing application for HDAC inhibitor givinostat as a treatment for Duchenne muscular dystrophy (DMD) has been accepted by the EMA, setting up an approval
The Federal Trade Commission (FTC) in the US has paused its legal challenge to Amgen's proposed acquisition of Horizon Therapeutics, setting up settlement talks that may g