On November 10, the U.S. Department of Health and Human Services announced that the FDA is initiating the removal of certain black box warnings from hormone replacement therapy products for menopause,...
An open-label, randomized trial found that daratumumab and hyaluronidase-fihj administered subcutaneously improved the risk of disease progression or death in patients with multiple myeloma. As a result,...
The FDA initiated approval of leucovorin calcium tablets to treat cerebral folate deficiency (CFD) following a systematic analysis demonstrating promise in this patient population.
The FDA recently announced the approval of rilzabrutinib tablets for adults with persistent or chronic immune thrombocytopenia who did not respond to immunoglobulins, anti-D therapy, or corticosteroids.
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The FDA has announced mandatory labeling changes for all opioid pain medications to more clearly communicate the risks associated with long-term use, including addiction, overdose, and other serious harms....
The FDA has announced the approval of the semaglutide injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis following promising interim analysis data.
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The FDA approved Zongertinib for adults with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations following prior systemic therapy.
The FDA announced on June 12 that it has approved pembrolizumab for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1.
The FDA announced the approval of darolutamide for treating metastatic castration-sensitive prostate cancer. This review was conducted under Project Orbis, which allows for concurrent submission and review...
