While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.
FDA approved yet another indication for pembrolizumab (Keytruda) to treat patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC).
FDA granted Fast Track designation to a popular diabetes drug to reduce the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure.
A women’s health organization is concerned about the safety and effectiveness of bremelanotide (Vyleesi) after FDA approved it to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.
The first FDA-approved device to reduce functional abdominal pain in younger patients with irritable bowel syndrome is now available to medical providers.
A record number of new oncology treatments launched in the US last year and spending on cancer drugs soared. Here are the top 6 cancer drug trends revealed in the report.