Food and Drug Administration (FDA)
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Sanofi and IGM Biosciences inked a collaboration deal for oncology, immunology and inflammation that could surpass $6 billion.
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”
The FDA amended its EUA for GlaxoSmithKline and Vir Biotechnology’s sotrovimab for COVID-19. The amendment relates specifically to the BA.2 Omicron sub-variant.
COVID-19 vaccines are the most-studied vaccines in history. This is partly why some data can appear so contradictory. For those and more COVID-19 stories, continue reading.
The acquisition of Sunosi transforms Axsome into a global commercial business that will support its operations as it moves closer to launching its treatments for depression and migraine.
UCB’s oral drug for seizures related to Lennox-Gastaut syndrome is now approved in the U.S. for patients ages two years and older.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will face its first big test since Aduhelm as it weighs the merits of Amylyx’s AMX0035 for ALS on Wednesday, March 30.
Novavax announced today that its protein-based Covid-19 vaccine, NVX-CoV2373, is included in two new clinical trials that will evaluate the vaccine as a potential Covid booster.
The FDA recommends a randomized trial to adequately assess drug efficacy and safety of P13K inhibitor drug candidates.
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