Almirall is within sniffing distance of EU approval for its IL-13 inhibitor lebrikizumab for atopic dermatitis, setting up a challenge to Sanofi and Regeneron’s market-lea
GSK's cancer unit has been given a fillip by the FDA with a broader-than-expected approval for JAK inhibitor momelotinib for anaemia associated with myelofibrosis, acquire
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)
Pfizer's Vydura has become the first drug in the oral GPCR receptor antagonist class to be recommended for routine NHS use as a treatment for acute migraine.