FDA Approvals

Nearly one in four patients with chronic hepatitis C (HCV) are denied initial approval for a drug therapy that treats… »   

The U.S. Food and Drug Administration on Thursday approved the sale of Breo Ellipta as a once-daily treatment for asthma… »   

Achillion Pharmaceuticals Inc said the U.S. Food and Drug Administration allowed it to resume the development of one of… »   

The U.S. Food and Drug Administration said on Friday it has approved a new drug to treat acute bacterial skin… »   

U.S. health regulators on Friday approved Qiagen NV’s gene-testing kit to identify those colorectal cancer patients most likely to… »   

Anika Therapeutics Inc said the U.S. Food and Drug Administration approved its drug to treat pain and improve joint mobility… »   

Bristol-Myers Squibb Co said the U.S. Food and Drug Administration approved its drug to treat rare and potentially fatal… »   

The U.S. Food and Drug Administration said on Monday it has approved Novo Nordisk’s drug Tretten to prevent bleeding in… »   

An oral immunotherapy aimed at grass and pollen allergies has a benefit and safety profile that supports its approval, according… »   

U.S. Food and Drug Administration staff reviewing data on Boston Scientific Corp’s novel anti-stroke device highlighted the implant’s failure to… »   

The drug saxagliptin (trade name: Onglyza) has been approved also as monotherapy in Germany since July 2013 for certain adults… »   

A third agent that acts directly against hepatitis C (HCV) has been approved, according to the company that makes the… »   

The U.S. Food and Drug Administration said on Friday it has expanded the approved use of the cancer drug… »   

GlaxoSmithKline and Theravance’s new inhaled lung drug Relvar has been approved in Europe to treat both asthma and chronic obstructive… »   

U.S. health regulators on Wednesday approved a drug to treat a rare and aggressive form of non-Hodgkin lymphoma developed by… »