FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...

The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...

T he FDA approved doxecitine and doxribtimine powder (Kygevvi) for thymidine kinase 2 deficiency (TK2d), an ultra-rare ...

UCB has scored an FDA approval for ultra-rare disease treatment Kygevvi, continuing the positive momentum for the Belgian ...

The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as 15 to treat severe depression.

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 ...

The U.S. Food and Drug Administration has approved Lynkuet, a new medication that does not contain hormones to treat hot ...

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 ...

FDA approves cancer drug belantamab mafodotin-blmf for relapsed multiple myeloma in combination with bortezomib and dexamethasone.

Elinzanetant belongs to a new class of drugs designed to target what is believed to be a key mechanism responsible for ...

DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of ...