The FDA declined to consider elamipretide for full approval in 2021 and rejected the company's application in May of 2025 ...
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 ...
The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as ...
UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian ...
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 FDA has approved Kygevvi (doxecitine and doxribtimine) for the treatment of TK2d in adults and pediatric patients with an age of symptom onset on or before 12 years.
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 ...
Rybelsus is now FDA-approved for managing cardiovascular health. Doctors say oral GLP-1s may reduce heart attack and stroke ...
In October 2025, the U.S. Food and Drug Administration (FDA) granted approval to multiple new cancer therapies and supportive ...
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of ...
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