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A $2.1 million gene therapy with the potential to cure beta-thalassemia, a lifelong blood disorder, is worth the price, according to the Institute for Clinical and Economic Review (ICER). Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) has rapped Bausch Health for making false and misleading claims for its topical psoriasis treatment Duobrii. Read More
The FDA released revised final guidance for drug manufacturers, packers and distributors on submitting promotional materials in both electronic and nonelectronic formats. Read More
Vanda Pharmaceuticals is suing the FDA, claiming the agency refuses to disclose why it won’t approve the company’s sleep disorder drug Hetlioz (tasimeleton) for jet lag. Read More
The European Medicines Agency’s (EMA) safety committee said it found no evidence for a causal link between the Pfizer/BioNTech and Moderna COVID-19 vaccines and very rare cases of autoimmune hepatitis (AIH). Read More
Dropping from a high of 47 requests for Regenerative Medicine Advanced Therapy (RMAT) designations in 2018, the FDA has received, so far, just 14 requests this year, according to new data from the FDA’s Center for Biologics Evaluation and Research (CBER). Read More
Claims by CofixRX for its iodine-containing nasal spray render it an unapproved new drug that is misbranded and adulterated, the FDA said, in a warning letter to the company in Rochester Hills, Mich. Read More
Last week’s Aduhelm coverage decision by the Centers for Medicare and Medicaid Services (CMS) raises the bar for three other antiamyloid antibodies in late-stage development: Eisai’s and Biogen’s lecanemab, Eli Lilly’s donanemab and Roche’s gantenerumab. It all depends on the evidence that the drugmakers provide in their submissions to the FDA. Read More