US FDA approves Journey Medical’s drug for long-term skin condition | Reuters
Excerpt from Reuters: “Journey Medical (DERM.O) said on Monday the U.S. Food and Drug Administration has approved its drug for the treatment of a long-term skin condition called rosacea, sending the company’s shares up nearly 12% before the bell.
The oral drug, branded Emrosi, was approved to treat inflammatory lesions associated with the disease, which mostly affects women and men in the age group of 30 to 60 years.” Read more.
Jazz Pharma loses lawsuit over FDA approval of rival sleep drug | Bloomberg Law
Excerpt from Bloomberg Law: “A federal judge ruled the FDA didn’t break orphan drug exclusivity when it approved a rival version of Jazz Pharmaceuticals PLC’s sleep drug Xywav.
Judge Amit P. Mehta of the US District Court for the District of Columbia agreed with the Food and Drug Administration when the agency said it had the authority to approve Avadel CNS Pharmaceuticals LLC’s Lumryz, a rival product of Jazz’s narcolepsy drug Xywav.
The FDA didn’t err in determining that Lumryz and Xywav are not the “same drug,” didn’t inexplicably depart from a “comparable safety” policy because there is no such policy, and didn’t act …” Read more.
Discontinuation of popular asthma medication, Flovent, linked with increased hospitalization | ABC News
Excerpt from ABC News: “Data from over 3 million people who had been using Flovent showed a 17.5% increase in asthma-related hospitalization in the three months after Flovent was discontinued, and a 24.1% increase in the following three to six months.
ICU admissions for asthma in those previously using Flovent increased 17.4% three months after discontinuation, and 23.1% three to six months after discontinuation.” Read more.
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