On February 19, 2016, the U. S. Food and Drug Administration approved palbociclib (IBRANCE Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

On February 5, 2016, FDA approved changes to the DAKLINZA(daclatasvir) label to expand the indication to include HCV genotype 1 infection and expand dosage recommendations to the following populations and to revise dosage recommendations for HCV genotype 3 subjects with compensated (Child-Pugh A) cirrhosis:

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Wonder-Erect Male Pills, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com , and possible in some retail stores.Image of Wonder-Erect Male Pills.

On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).

The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers.

The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors.

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina.