March 23 (Reuters)—Roche Holding AG said on Monday it has received the U.S. Food and Drug Administration‘s clearance to test its rheumatoid arthritis treatment on patients hospitalized with severe pneumonia caused by the coronavirus. The company said it was beginning a late-stage study to test the drug in what would be the first well-controlled study…
FDA Advisory Committees Reject Oxycodegol (NKTR-181) Application
FDA advisory committees rejected the new drug application for oxycodegol, an opioid analgesic, due to a lack of data regarding it’s potential for abuse…
FDA Rheumatology Update: New Drug Approvals, Plus Expanded Drug Indications & Safety Concerns
Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
New Gabapentinoid Warning Labels
Gabapentinoid products will now carry warning labels about the risks of respiratory distress when combined with opioids and other nervous system and respiratory depressants…
FDA Action on Loperamide Misuse; Plus Phase 1 Trials for BAT2506 Biosimilar Begin
The FDA has limited the package size of some over-the-counter loperamide products to prevent its potential misuse and abuse…
Trump Nominates MD Anderson Oncologist as U.S. FDA Commissioner
(Reuters)—U.S. President Donald Trump has nominated Stephen Hahn, MD, chief medical executive of the University of Texas MD Anderson Cancer Center, to lead the U.S. Food and Drug Administration (FDA), the White House said on Friday. Dr. Hahn, a radiation oncologist who has been at MD Anderson in Houston since 2015, if confirmed would follow…
FDA Approves Ixekizumab for Treating Active Ankylosing Spondylitis
Data from two phase 3 studies were used to support the FDA’s approval of ixekizumab for adults with ankylosing spondylitis…
FDA Approves the Biosimilar Hadlima (Adalimumab-bwwd)
Hadlima (adalimumab-bwwd), which is biosimilar to adalimumab, is now FDA approved to treat multiple autoimmune diseases…
FDA Approves Upadacitinib for RA
Results from multiple phase 3 clinical trails have led to the FDA approval of upadacitinib to treat patients with moderate to severe active RA…
FDA Approves AbbVie’s New Rheumatoid Arthritis Drug
(Reuters)—The U.S. Food and Drug Administration (FDA) on Friday approved AbbVie Inc.’s new treatment for rheumatoid arthritis (RA), a win for the drugmaker seeking to widen its portfolio as its blockbuster flagship therapy Humira (adalimumab) faces competition. The drug, Rinvoq (upadacitinib), is a JAK inhibitor. It is set to compete with Pfizer Inc.’s Xeljanz (tofacitinib)…
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