January 21, 2015

The Food and Drug Administration on Wednesday announced approval for Cosentyx (secukinumab), indicated for the treatment of adults with moderate to severe plaque psoriasis.

 

January 20, 2015

Teva Pharmaceutical on Tuesday announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA vs. Sandoz et al. that reversed the Federal Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for Copaxone (glatiramer acetate injection) 20 mg/mL.

January 16, 2015

A report published in the Jan. 16 Morbidity and Mortality Weekly Report estimates that getting a flu vaccine this season reduced a person’s risk of having to go to the doctor because of flu by 23% among people of all ages.

January 16, 2015

AbbVie announced that the Food and Drug Administration has approved its Duopa (carbidopa and levodopa) enteral suspension, which is used to treat motor fluctuations for people with advanced Parkinson's disease. 

 

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.

 

January 13, 2015

NACDS president and CEO Steve Anderson released a statement highlighting the important role that pharmacists play and praised the increased recognition by lawmakers and the nation’s governors.

 

January 12, 2015

Halfway through the 2014-15 flu season, the Centers for Disease Control and Prevention reported that antiviral medications are being underutilized. 

January 12, 2015

The Council for Responsible Nutrition Foundation on Monday announced it has pledged additional grants — now totaling more than $2.1 million — to the National Advertising Division.

January 9, 2015

Daiichi Sankyo Co., Limited on Friday announced that the Food and Drug Administration has approved Savaysa (edoxaban) tablets, an oral, once-daily selective factor Xa-inhibitor that reduces the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. 

 

January 8, 2015

Camber Pharmaceuticals on Thursday announced the launch of valsartan tablets USP in 40-, 80-, 106- and 320-mg dosage strengths.

 

January 7, 2015

With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.

January 7, 2015

Teva Pharmaceutical on Tuesday announced the Food and Drug Administration approved the launch of the company's valsartan tablets, the generic version of Diovan tablets from Novartis. 

 

January 6, 2015

Vermont Attorney General Bill Sorrell is investigating generic drug price inflation.

January 5, 2015

The Consumer Healthcare Products Association thanked President Obama for signing the Designer Anabolic Steroid Control Act into law last month.

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 29, 2014

Novo Nordisk last week announced that the Food and Drug Administration approved the company's new drug application for Saxenda, a once-daily glucagon-like peptide-1 receptor agonist used as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults.

December 29, 2014

Genentech last week announced that the Food and Drug Administration approved a supplemental biologics license application for Gazyva to be used in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia.

December 29, 2014

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

December 18, 2014

As out-of-pocket expenses rise, many Americans say that the affordability of basic medical care is a hardship and, as a result, some are forgoing treatment because they are worried about cost, according to a recent national poll conducted by The New York Times and CBS News.

December 18, 2014

The U.S. Senate Special Committee on Aging unveiled a new bipartisan report earlier this week that focuses on ways to increase the use of generic drugs within the Medicare Part D program.

December 17, 2014

To date, the Food and Drug Administration's Center for Drug Evaluation and Research has approved 35 novel new drugs in 2014, compared to 27 in 2013. 

December 17, 2014

The Food and Drug Administration on Wednesday approved Xtoro (finafloxacin otic suspension), a new drug that's used to treat acute otitis externa, commonly known as swimmer's ear. 

December 16, 2014

Use of cigarettes, alcohol and abuse of prescription pain relievers among teens has declined since 2013, while marijuana use rates were stable, according to the 2014 Monitoring the Future survey, released Tuesday.