The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...
UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian ...
T he FDA approved doxecitine and doxribtimine powder (Kygevvi) for thymidine kinase 2 deficiency (TK2d), an ultra-rare ...
The U.S. Food and Drug Administration has approved elinzanetant, a new non-hormonal treatment to help women manage menopause ...
The approval was based on data from a Phase II trial, two retrospective chart review studies and an expanded access programme ...
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 ...
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 ...
Elinzanetant belongs to a new class of drugs designed to target what is believed to be a key mechanism responsible for ...
FDA approves cancer drug belantamab mafodotin-blmf for relapsed multiple myeloma in combination with bortezomib and dexamethasone.
The FDA has approved the Tendyne device to replace the mitral heart valve through a small incision between the ribs. Dr. Paul ...
A biotech stock with strong FDA approval odds this November may see limited upside amid a full valuation and a pending lawsuit.