October 10, 2014

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

October 9, 2014

Congress and the sports nutrition industry independently called upon the Food and Drug Administration to act on removing an untested synthetic stimulant that was found in 12 products marketed as sports nutrition supplements.

October 9, 2014

The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products. 

October 7, 2014

The Network for Excellence in Health Innovation on Monday announced the recipients of its 2014 Innovators in Health award, which recognizes individuals whose work reflects the spirit of NEHI and embraces the mission of improving the quality of health care and reducing costs for patients and their families. 

October 6, 2014

Healthcare Distribution Management Association released a statement in support of the FDA’s “Know Your Source” campaign.

October 3, 2014

SpermCheck on Thursday launced SpermCheck Fertility, an FDA-approved at-home screening test that determines with 98% accuracy whether a man has a normal or low sperm count.

September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 

September 16, 2014

Baxter International announced that the Food and Drug Adminsitration approved Rixubis [coagulation factor IX (recombinant)] for the treatment, control and prevention of bleeding episodes, as well as perioperative management, in children with hemophilia B. 

September 11, 2014

Medivation and Astellas Pharma on Wednesday announced that the Food and Drug Administration approved a new use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer.

September 10, 2014

The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products in much the same way that the "Orange Book" lists pharmaceuticals. 

September 9, 2014

The Food and Drug Administration is on pace to match or exceed the 39 novel new medicines approved in 2012.

September 2, 2014

UCB on Monday announced that the Food and Drug Administration has approved a supplemental new drug application for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ages 17 years and older.

August 25, 2014

Pharmaceutical company Iroko announced today that a new version its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration.

August 21, 2014

GlaxoSmithKline announced FDA approval for Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for the treatment of asthma in patients 12 years of age and older.

August 21, 2014

The Food and Drug Administration cleared South Korean company Philosys’ Gmate blood-sugar monitoring device for U.S. marketing on Aug. 15.

August 20, 2014

iHealth Lab recently launched its iHealth Align, one of the world’s smallest, FDA-approved mobile blood-glucose monitors.

August 19, 2014

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

August 19, 2014

PharmaJet, the developer of a needle-free injection technology to administer medications and vaccines to patients, and bioCSL, the maker of Afluria (influenza vaccine) on Tuesday announced the Food and Drug Administration has approved the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria in individuals ages 18 years to 64 years.

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

August 11, 2014

The recent release of Colgate Total’s application submitted to the Food and Drug Administration, which included 35 pages summarizing toxicology studies on triclosan, is raising some eyebrows as some are wondering if the FDA did its due diligence in approving Total 17 years ago, according to a report from Bloomberg Businessweek.

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 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. 

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.