10/16/2014 - 10:52am

The Food and Drug Administration has granted approval to Esbriet (pirfenidone), as well as Ofev (nintedanib), to treat idiopathic pulmonary fibrosis — a condition in which the lungs scar over time.

10/15/2014 - 2:52pm

As the Food and Drug Administration begins to explore ways to improve its user-fee program for generic drugs, the Generic Pharmaceutical Association and its members have weighed in with suggestions on how to shore up the law to ensure that it helps bring generics to market faster and provides benefits across the entire healthcare system.

10/15/2014 - 2:52pm

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

10/15/2014 - 2:52pm

What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.

10/15/2014 - 1:09pm

The U.S. Supreme Court on Wednesday heard arguments from Teva Pharmaceutical Industries in defense of the patent protecting its $4 billion multiple sclerosis drug Copaxone, according to a Reuters report. 

10/14/2014 - 2:42pm

U.S. Sen. Bernie Sanders, I-Vt., and U.S. Rep. Elijah Cummings, D-Md., earlier this month launched an investigation into soaring generic drug prices.

10/14/2014 - 2:18pm

Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. 

10/14/2014 - 8:50am

Adults in the United States suffered from approximately 14 million major medical conditions attributable to smoking, according to a study published in the journal JAMA Internal Medicine Monday.

10/10/2014 - 1:34pm

The Food and Drug Administration on Friday approved Gilead's Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.