October 10, 2014

The Food and Drug Administration on Friday approved Akynzeo (netupitant and palonosetron) for the treatment of nausea and vomiting in patients who are undergoing cancer chemotherapy.

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The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products.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 9, 2014

Salix Pharmaceuticals on Thursday announced that the Food and Drug Administration granted final approval for the company's Uceris (budesonide) rectal foam for patients with mild-to-moderate distal ulcerative colitis. 

October 8, 2014

The Pharmaceutical Research and Manufacturers of America on Tuesday released a new report highlighting the number of investigational cancer medicines that did not succeed in clinical trials. 

October 8, 2014

Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission for hydrocodone bitartrate extended-release tablets.

October 7, 2014

Actavis and Durata Therapeutics on Monday announced that they have entered into a definitive merger agreement.

October 7, 2014

Biopharmaceutical company Chimerix on Monday announced that brincidofovir has been provided for potential use in patients with Ebola virus at the request of treating physicians.

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.

September 30, 2014

Salix Pharmaceuticals and Progenics Pharmaceuticals announced that the Food and Drug Administration approved Relistor (methylnaltrexone bromide) subcutaneous injection in 12-mg dosage strength to treat constipation in patients taking opioids for chronic, non-cancer pain. 

September 25, 2014

AbbVie on Thursday announced that the Food and Drug Administration approved Humira (adalimumab) as a treatment for pediatric Crohn's disease patients ages 6 years and older when other treatments haven't worked well enough.

 

September 24, 2014

In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

September 23, 2014

A bill has been introduced that lawmakers say would “close federal loopholes” and increase consumer access to generic drugs while boosting market competition.

September 19, 2014

The Food and Drug Administration on Thursday approved Trulicity (dulaglutide), a once-a-week injection to improve blood-sugar levels in adults with Type 2 diabetes. 

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

The Food and Drug Administration on Tuesday announced approval for Movantik (naloxegol), a treatment for opioid-induced constipation in adults.

September 15, 2014

Mylan announced that its subsidiary, Mylan Labs Limited, has signed an agreement with Gilead Science under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single-tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. 

September 11, 2014

The Food and Drug Administration approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as a chronic weight-management option. 

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

Sanofi Pasteur announced that the Food and Drug Administration approved the use of Menactra [meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine] as a booster vaccination against meningococcal disease in people ages 15 years through 55 years. 

September 9, 2014

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