Soon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.
Scott Gottlieb, MD, was sworn in as the new FDA commissioner and ushers in a new era.
Walmart, CVS Health, and a number of other healthcare organizations are supporting a new multi-million dollar consumer campaign to combat high prescription drug prices.
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.
In what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
FDA said this week that it is restricting the use of codeine and tramadol medicines in children. The drug’s labels will now include a contraindication that codeine should not be used to treat pain or cough, and that tramadol should not be used to treat pain, in children younger than 12 years.
FDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
Two recent studies demonstrate that pirfenidone (Esbriet, Genentech) prolongs life expectancy by 2.47 years for IPF patients and that Esbriet and nintedanib (Ofev, Boehringer Ingelheim) reduce the decline in lung function.