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 ...
UCB has announced FDA’s approval of Kygevvi (doxecitine and doxribtimine) for the treatment of adults and pediatric patients ...
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.
A groundbreaking FDA approval offers the first-ever treatment for ultra-rare Thymidine Kinase 2 Deficiency (TK2d). KYGEVVI, a ...
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 ...
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Restylane Lyft with Lidocaine for ...
UniQure shares soared on positive AMT-130 Huntington's disease data, but plunged after the FDA reversed its stance on ...
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