May 1, 2015

The Food and Drug Administration is calling for safety and efficacy data on OTC monographed antiseptics. 

April 21, 2015

Less than 1% of all pharmaceutical reports to American Association of Poison Control Centers associated with homeopathic medicines, the American Association of Homeopathic Pharmacists told the Food and Drug Administration.

April 3, 2015

The New York Attorney General on Thursday joins forces with 14 AGs from across the country.

April 2, 2015

Alere's i Strep A test received marketing clearance from the Food and Drug Administration on Thursday. 

April 1, 2015

The recently Food and Drug Administration-approved AirStrip Sense4Baby monitoring system will enable remote self-administered non-stress tests as part of a comprehensive prenatal care model. 

March 23, 2015

Acura Pharmaceutical's Nexafed extended release demonstrated bioequivalence to Sudafed 12-hour tablets. 

March 13, 2015

An Alliance for Aging Research survey found that consumers want to maintain nonprescription access to acetaminophen. 

February 20, 2015

FDA makes direct-to-consumer genetic testing easier to bring to market. 

February 17, 2015

The Food and Drug Administration last week issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

January 30, 2015

Diplomat Pharmacy announced Thursday that the Food and Drug Administration has approved an expanded indication of Imbruvica (ibrutinib) for the treatment of Waldenström’s macroglobulinemia (WM).

January 20, 2015

The Food and Drug Administration has expanded the age indication for Natroba (spinosad) topical suspension 0.9% to include children 6 months of age and older who have head lice infestations (pediculosis capitis).

January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

December 30, 2014

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

December 23, 2014

Specialty pharmacy Diplomat Pharmacy has announced that it will stock Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets), which was approved Dec. 19 by the Food and Drug Administration.

December 23, 2014

Teva Pharmaceutical today announced that the Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.

December 22, 2014

The Food and Drug Administration granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.

December 22, 2014

The Food and Drug Administration has granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.

December 22, 2014

The Food and Drug Administration has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

December 22, 2014

The Food and Drug Administration has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

December 19, 2014

Teva Pharmaceutical announced that the Food and Drug Administration approved QNasl (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis in children ages 4 years to 11 years.

December 17, 2014

Ipsen Biopharmaceuticals on Tuesday announced that Somatuline Depot (lanreotide) Injection 120 mg (referred to as Somatuline) was approved by the U.S. Food and Drug Administration for the treatment of gastroenteropancreatic neuroendocrine tumors.

December 12, 2014

Sanofi Pasteur announced that the FDA approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine.

December 11, 2014

The Food and Drug Administration on Wednesday approved Gardasil 9 for the prevention of certain diseases caused by nine types of human papillomavirus.