CLINICAL

Amputation risk possible with diabetes drugs, FDA warnsBased on new data from 2 large clinical trials, FDA is warning that these blockbuster type 2 diabetes medications can cause an increased risk of leg and foot amputations.
New FDA lead ushers in new eraScott Gottlieb, MD, was sworn in as the new FDA commissioner and ushers in a new era.
Immuno-oncology bladder drug wins approvalSoon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.
Costly new ALS treatment approvedFDA recently approved the first new treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, in more than 20 years.
Campaign gears up to combat high drug pricesWalmart, 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 approves first targeted leukemia drug for certain patients, plus 2 moreLate 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.
New abuse-deterrent opioid availableA new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
FDA clears second Remicade biosimilarIn 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: Limit codeine and tramadol use in kidsFDA 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.
Hep C drugs approved for kidsFDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.

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