FDA approved the third oncology drug in the US that targets a key genetic driver of cancer, rather than a specific tumor.
While FDA’s drug approval time is generally improving, the agency needs to speed up generic drug application reviews, according to a new report.
FDA approved yet another indication for pembrolizumab (Keytruda) to treat patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC).
Drug to treat prostate cancer is expected to produce a major windfall for two pharma makers.
FDA approved the first and only ready-to-use insulin for IV infusion in hospitals and acute care settings.
Asthma patients may soon treat themselves with first-ever digital maintenance inhaler.
The first FDA-approved device to reduce functional abdominal pain in younger patients with irritable bowel syndrome is now available to medical providers.
FDA cleared alpelisib (Piqray), the first PI3K inhibitor to treat breast cancer, to be used in combination with fulvestrant (Faslodex).
FDA approved some important new therapies, including the first anticoagulant for children, an injectable for diabetic retinopathy, and a treatment for renal cell carcinoma.
While FDA approved the second biosimilar drug to Enbrel, the success of the medication hinges on a pending lawsuit.