Adamis’ epinephrine injection promises to be a lower-cost alterative to EpiPen.
The first generic Truvada for treating and preventing HIV will be available, but when?
FDA approves Isentress at a higher dose for HIV-1 infected patients.
FDA has approved the first generic versions of Strattera (atomoxetine) for the treatment of attention deficit/hyperactivity disorder.
FDA approves ribociclib plus letrozole to treat a subset of advanced breast cancer patients.
FDA expanded the use of ivacaftor (Kalydeco, Vertex Pharmaceuticals) to treat cystic fibrosis.
Soon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.
FDA recently approved the first new treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, in more than 20 years.
Late last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.
A new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.