August 15, 2014

Pfizer’s Prevnar 13 vaccine for pneumonia has been recommended for use by patients 65 years old and up by the Centers for Disease Control and Prevention’s immunization practices advisory committee. 

August 15, 2014

The Food and Drug Administration announced approval of a new use for Avastin (bevacizumab), to treat patients with persistent, recurrent or late-stage cervical cancer.

August 14, 2014

The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia.

August 11, 2014

Janssen Pharmaceuticals received approval from the Food and Drug Administration for Invokamet, a fixed-dose therapy that combines canagliflozin and metformin hydrochloride in a single tablet.

August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

August 8, 2014

The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections.

August 7, 2014

Following Walgreens' decision to acquire the rest of the Alliance Boots business — and to keep its headquarters based in the greater Chicago area — Sen. Dick Durbin, D-Ill., weighs in on the decision in a brief video.

August 6, 2014

Michael Taylor, who currently serves as the Food and Drug Administration's deputy commissioner for foods and veterinary medicine, outlined the importance for companies to adhere to gluten-free guidelines in a post on FDA Voice.

August 5, 2014

New York City's Department of Health and Mental Hygiene said a man who was tested for Ebola at Mount Sinai Hospital is "unlikely" to have the virus. The patient was admitted to the hospital early Monday with a fever and gastrointestinal problems. He recently visited a West African country where Ebola was reported, according to the Washington Post.

August 4, 2014

The Council for Responsible Nutrition on Friday submitted comments to the Food and Drug Adminisration regarding the agency's proposed rule changes of nutrition and supplement facts labels. 

August 4, 2014

The Food and Drug Administration approved Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are younger than 8 years of age.

August 4, 2014

The Pennsylvania House of Representatives unanimously adopted House Resolution 938, which designates August as National Immunization Awareness Month, the legislature announced Monday.

August 1, 2014

The Food and Drug Administration announced approval for Boehringer Ingelheim's Jardiance tablets.

August 1, 2014

The Food and Drug Administration approved Striverdi Respimat (olodaterol) inhalation spray for the treatment of chronic obstructive pulmonary disease, including chronic bronchitis and/or in patients with emphysema that are experiencing airflow obstruction, the agency announced.

July 31, 2014

CVS/pharmacy is the first pharmacy in the nation to earn the new Community Pharmacy accreditation from URAC.

July 31, 2014

The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.

July 30, 2014

Since the Affordable Care Act was signed in 2010, more than 8 million older and disabled Americans with Medicare benefits have saved $11.5 billion on prescription drugs.

July 30, 2014

Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.

July 29, 2014

Legislation that would speed up and streamline the Food and Drug Administration’s approval process for new sunscreen ingredients passed the House on Monday, according to published reports.

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 29, 2014

A bipartisan bill that calls for a collaborative, coordinated approach to curbing prescription drug abuse and safeguarding patients is headed to the U.S. House for a vote.

July 29, 2014

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

July 28, 2014

The Food and Drug Administration on Monday expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia who carry a deletion in chromosome 17.

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.