The FDA warning letters mostly went to cosmetic websites. In each case, the FDA said the companies were offering unofficial ...
The FDA approved linaclotide (Linzess) capsules to treat irritable bowel syndrome with constipation (IBS-C) in children age 7 ...
A University of Manchester study reveals a drug approved for use in other conditions could be repurposed as a preventive ...
It is fair to say (no matter what else can be said) that the current administration is outcome- rather than process-driven. This general ...
FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...
Treatments for asthma, chronic rhinosinusitis with nasal polyps, dyslipidemia, Cushing syndrome, gonorrhea, HSCT-associated thrombotic microangiopathy, marginal zone lymphoma, motion sickness, ...
UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian ...
In October 2025, the U.S. Food and Drug Administration (FDA) granted approval to multiple new cancer therapies and supportive ...
Developers of biosimilars -- medicines that are near-identical copies of biologic drugs -- will no longer be required to conduct clinical trials to prove effectiveness.
MedPage Today on MSN
Ultra-Rare Mitochondrial Disease Gets First FDA-Approved Drug
T he FDA approved doxecitine and doxribtimine powder (Kygevvi) for thymidine kinase 2 deficiency (TK2d), an ultra-rare ...
The company intends to meet with the FDA to discuss results that showed a level of improvement on a marker of muscle stability that one executive described as a “home run.” BridgeBio’s market value ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback