Medpage Today on MSN
FDA Approves IV Antibiotic for Complicated UTIs
The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...
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 U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...
GlobalData on MSN
FDA approves UCB’s Kygevvi for genetic mitochondrial disease
The approval was based on data from a Phase II trial, two retrospective chart review studies and an expanded access programme ...
DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of ...
A biotech stock with strong FDA approval odds this November may see limited upside amid a full valuation and a pending lawsuit.
After a three-month delay, the FDA has now rejected an approval request based on the RWE. According to Biohaven, the FDA’s complete response letter “cited issues that can be inherent to real-world ...
The U.S. Food and Drug Administration has approved Lynkuet, a new medication that does not contain hormones to treat hot ...
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 ...
Rybelsus is now FDA-approved for managing cardiovascular health. Doctors say oral GLP-1s may reduce heart attack and stroke ...
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