An FDA advisory committee has voted by a huge margin that BrainStorm’s stem cell therapy for amyotrophic lateral sclerosis (ALS) – NurOwn – does not have enough data to su
Shares in Travere Therapeutics have lost more than 40% of their value after the company said that a trial designed to confirm the benefits of its recently approved Filspar
Shares in ARS Pharmaceuticals were in freefall in pre-market trading this morning as it emerged that the FDA had declined to approve its application for its lead product,
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