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FDA Reauthorization Act heads to Trump’s desk after Senate passage
WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.
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FDA approves Imbruvica expansion to treat chronic graft versus host disease
SILVER SPRING, Md. — Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) has a new indication. The Food and Drug Administration on Wednesday approved the drug to treat adults with chronic graft versus host disease after one or more treatments have failed.
This approval makes Imbruvica the first FDA-approved treatment for the illness, which afflicts patients who have received hematopoietic stem cell transplantation to treat blood or bone marrow cancers. The illness occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues.