We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Members of the FDA’s Psychopharmacological Drugs Advisory Committee voted strongly against recommending MDMA, also known as “ecstasy,” as a potential treatment for post-traumatic stress disorder (PTSD) at their meeting on Tuesday. Read More
How can regulators judge the efficacy and safety of a product that makes patients feel so good, so quickly, that trial blinding is impossible, and the drug’s positive effects may carry abuse potential? Read More
This edition of Quick Notes focuses on FDA drug approvals for relapsed or refractory lymphoma, a nighttime non stimulant liquid ADHD treatment for children, extensive-stage non-small cell lung cancer and an mRNA vaccine for RSV. Read More
Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections. Read More
Sanofi and development partner Regeneron are riding a regulatory roller coaster, with the EU giving Dupixent (duplilumab) a nod for chronic obstructive pulmonary disease (COPD) even as the FDA hedges, asking for more phase 3 data before granting the new indication. Read More
The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will attempt to balance the benefits of Novo Nordisk’s once-weekly insulin injection Awiqli with an increased risk of moderate and severe hypoglycemia at its May 24 meeting. Read More
Dynavax announced it received an FDA complete response letter (CRL) on its sBLA for Heplisav-B vaccine because the third-party clinical trial site operator destroyed the data for approximately half the subjects. Read More
The FDA has joined forces with the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA) on a plan to regulate genetically modified organisms and biotechnology products for humans. Read More