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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 company is working with regulators in the U.S., Europe and the UK to find ways to gain approval for this drug for the treatment of COVID-19. 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
Veru has stopped a phase 3 study of its COVID-19 treatment sabizabulin after an interim safety analysis found that the drug overwhelmingly reduced the risk of death by 55 percent in patients with moderate-to-severe disease. 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