The FDA has approved Eli Lilly’s Emgality (galcanezumab-gnlm) for the treatment of episodic cluster headache in adults, giving the calcitonin gene-related peptide (CGRP) antibody a key poin
bluebird bio has its first ever product approval, getting a green light from the EMA for Zynteglo, its ex vivo gene therapy for the rare blood disorder beta thalassaemia.
Mitsubishi Tanabe Pharma has withdrawn its EU application for ALS drug Radicava (edaravone), citing ‘unwarranted’ additional data requirements from the EMA.
Amarin’s cardio drug Vascepa (icosapent ethyl) has been granted Priority Review designation by the FDA after trial results showed it could reduce the risk of major cardio events by up to 25
AstraZeneca has decided to trim back its 2015 alliance with Inovio Pharmaceuticals, which focused on combining the biotech’s DNA cancer vaccines with AZ’s cancer immunotherapies.
The FDA has granted Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Aliqopa (copanlisib) for marginal zone lymphoma (MZL) patients who have received two prior therapies.