Comparisons of Embeline E (clobetasol propionate cream-emollient), a class I ranking topical steroid, to class II products like Diprolene AF are misleading because the "comparison implies that Embeline E is superior to the other product," FDA says in a May 20 letter to the company. "However, Healthpoint does not explain that there are differences in efficacy and safety with class I and class II products." The agency also object to the statement in promotional brochures that Embeline E "is the new drug of choice." "As a generic product of the innovator, Temovate E, Embeline E would not be considered a 'new drug,'" FDA said
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.
The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.
US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.
