Astellas Issues Recall of One Lot of Prograf 0.5 mg and One Lot of Astagraf XL 0.5 mg Because Bottles Shipped to U.S. May Contain Empty Capsules New Drug Approvals Tevimbra Approved in U.S. for First-line Treatment of Gastric and Gastroesophageal Junction Cancers in Combination with Chemoth...
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distribution, and use. In addition to REMS and labeling requirements, FDA addresses product integrity and supply chain security, adverse event reporting, surveillance (including the Sentinel program), information dissemination, off-label use, direct-to-consumer advertising, and postmarket studies. The ...
Encouragingly, in the recently published multinational, open-label, and parallel-group randomized trial examining safety, tolerability, and efficacy of up-titration of guideline-directed medical therapy for acute heart failure (STRONG-HF), patients were randomized to usual care or “intensive” medical...