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The news comes less than four weeks after the FDA’s Cardiovascular and Renal Drugs Advisory Committee said the drug should not be approved, citing concerns about the drug’s safety. Read More
Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates), already approved for narcolepsy, has won a new indication as a treatment for idiopathic hypersomnia (IH) in adults. Read More
In a study of 100 patients randomized to receive Nexviazyme or another FDA-approved enzyme replacement therapy, the two treatments showed similar efficacy in improving lung function. Read More
The FDA’s approval of Aduhelm “raised concerns due to alleged scientific disputes within the FDA, the advisory committee’s vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA’s use of the accelerated approval pathway,” HHS said. Read More
Last month, the FDA granted the Pfizer-BioNTech COVID-19 vaccine a priority review for full approval, and the agency has also reallocated staff resources and said it is taking an “all hands on deck” approach. Read More
The FDA has granted Eiger BioPharmaceuticals Breakthrough Therapy designation for avexitide for the treatment of congenital hyperinsulism, an ultra-rare, life-threatening pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to half of children affected. Read More
There is currently no approved vaccine for RSV, a common respiratory virus that generally causes cold-like symptoms but can be fatal for elderly adults and young children. Read More