The FDA approved two new oral therapies to treat uncomplicated urogenital gonorrhea. Both treatments demonstrated comparable effectives when compared to standard treatment.
The US Food and Drug Administration has approved mitapivat tablets for the treatment of anemia in adults with alpha- or beta-thalassemia, offering a new oral option supported by randomized clinical trial...
The FDA has cleared a once-daily oral semaglutide treatment for adults with obesity or overweight and weight-related conditions, based on phase 3 OASIS 4 trial results demonstrating significant mean weight...
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,...
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,...
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.
...
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.
...
The FDA approved Zongertinib for adults with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations following prior systemic therapy.
