FDA says even after a March recall of the dietary supplement found to contain the active pharmaceutical ingredient benzamidenafil for erectile dysfunction, Century City, Calif.-based Bodee continued promoting Zencore Plus as a new and misbranded drug. FDA's July 27 warning letter notes Zencore Plus makes unauthorized structure/function claims, is not generally recognized as safe and effective, fails to declare the presence of benzamidenafil and neglects to warn users of potential side effects
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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.’
It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.
Health Canada’s proposal to no longer require biosimilar manufacturers to prove the safety and efficacy of their product through Phase III clinical trials marks a pivotal change in Canada’s regulatory approach.
Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.
