The U.S. Food and Drug Administration is implementing a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
Implementation of the Affordable Care Act (ACA) is only one of the factors forcing a rapid...
Orexigen Therapeutics has resubmitted the Contrave New Drug Application to FDA. Contrave (...
The European Commission has fined pharmaceuticals giants Johnson & Johnson and Novartis a combined $22 million for colluding to delay the entrance of a cheap generic form of a pain killer to the Dutch market.
Harmless lung cancer? A provocative study found that nearly 1 in 5 lung tumors detected on CT scans are probably so slow-growing that they would never cause problems. The analysis suggests the world's No. 1 cause of cancer deaths isn't as lethal as doctors once thought.
Navidea Biopharmaceuticals announced today that the FDA has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.
Shares of Acura Pharmaceuticals Inc. rose Monday after the company said it met with federal regulators to discuss a new version of the painkiller hydrocodone that uses the company's abuse-resistant technology. Acura said the meeting with the Food and Drug Administration focused on a mid-stage study of a mixture of hydrocodone and acetaminophen that is designed to be harder to abuse.
Hemispherx Biopharma today announced that its Phase 1/2 clinical trial at the University of Alabama Vaccine Research Clinic is now being expanded based on an analysis of safety results to date conducted by both the Food and Drug Administration and a Data Monitoring Committee, the latter group comprised of a team of independent clinical, basic research, and statistical professionals.
Princeton University has announced that a vaccination program with Novartis meningococcal serogroup B (MenB) vaccine, Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), began today following a campus outbreak that has affected at least eight students.
U.S. health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences Inc. that is expected to offer a faster, more palatable cure to millions of people infected with the liver-destroying virus.
The Food and Drug Administration on Friday approved the first drug to treat an unusual condition that causes painful, curved erections in men. The agency said it approved the biotech drug Xiaflex to treat Peyronie's disease, which causes an abnormal bend in the penis during erection.
There's more evidence that U.S. births may be leveling off after years of decline. The number of babies born last year only slipped a little, and preliminary government figures released Friday indicate that trend continued through the first six months of this year.
The European Medicines Agency has started an in-depth review of the benefits and risks of the leukemia medicine Iclusig, particularly the risk of blood clots or blockages in the arteries or veins that is associated with the medicine.
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorization to FluenzTM Tetra. Fluenz Tetra is a nasally administered four-strain live attenuated influenza vaccine for the prevention of influenza in children and adolescents from 24 months up to 18 years of age
Triplets-and-more increasingly are the result of drugs given to women to make them produce eggs — not from using multiple embryos from IVF, or lab-dish fertilization, new research shows.
The Food and Drug Administration said Wednesday that it reached a $1.25 million settlement with a division of Johnson & Johnson over allegations that it knowingly shipped faulty sterilization equipment used by hospitals.
Immunomedics said today its cancer drug IMMU-132 will receive orphan drug incentives as a treatment for small cell lung cancer. The Morris Plains, N.J., company said IMMU-132 is in mid-stage testing as a treatment for small cell lung cancer and other types of solid tumors.
Arca believes it has identified genetic variations that predict whether a patient will be helped by treatment with the drug Gencaro. The company said Gencaro could be the first genetically targeted therapy for atrial fibrillation, a type of irregular heartbeat.
President Barack Obama announced a new initiative at the National Institutes of Health in pursuit of a cure for HIV, saying his administration is redirecting $100 million into the project to find a new generation of therapies.
The co-owner of a now-defunct Virginia drug company has pleaded guilty to illegally importing Botox and other prescription drugs and selling them to physicians in violation of the Food and Drug Administration's regulatory scheme.
Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) has extended the initial Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc fusion protein candidate for hemophilia B.
AcelRx Pharmaceuticals, Inc. has announced that the Zalviso New Drug Application (NDA) was accepted for filing by the FDA on November 26, 2013. The acceptance for filing of the NDA indicates the FDA has determined that the application is sufficiently complete to permit a substantive review.
Specialty drugmaker BTG PLC has received U.S. approval to market an injectable drug to treat patients with varicose veins. The drug, Varithena, is pharmaceutical foam dispensed from a canister device.
Purdue Pharma L.P. announced that the FDA has accepted for review a New Drug Application (NDA) for Targiniq ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain. he NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled U.S. clinical trial with 600 opioid-experienced patients as well as supporting data from other clinical studies.
A government study offers a new theory on why the whooping cough vaccine doesn't seem to be working as well as expected. The research suggests that while the vaccine may keep people from getting sick, it doesn't prevent them from spreading whooping cough — also known as pertussis — to others.
The Food and Drug Administration is lifting severe safety restrictions on the former blockbuster diabetes pill Avandia, citing recent data suggesting that the much-debated medication does not increase the risk of heart attack.
The Food and Drug Administration has ordered Google-backed genetic test maker 23andMe to halt sales of its personalized DNA test kits, saying the company has failed to show that the technology is supported by science.
Orexigen Therapeutics Inc. shares jumped Monday after the drugmaker said it expects to resubmit its application for the potential weight-loss treatment Contrave to federal regulators in the next few weeks. The La Jolla, Calif., company said Monday that the Food and Drug Administration could...
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