The FDA has approved a new injectable drug from GlaxoSmithKline plc for adults with Type 2 diabetes. The agency cleared the company's drug, Tanzeum, to help patients control their blood sugar levels, in combination with diet and exercise.
A high-tech screening tool for cervical cancer is facing pushback from more than a dozen U.S....
Merck has announced that FDA has approved GRASTEK ® (Timothy Grass Pollen Allergen Extract)...
BioMarin Pharmaceutical today announced that the FDA granted KUVAN(R) (sapropterin...
Bristol-Myers Squibb Company announced today the submission of a new drug application (NDA) on April 4, 2014 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz®, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective.
Concerns about electronic cigarettes, including flavors and marketing that could appeal to young people, underscore the need to regulate the fast-growing industry, according to a Congressional report released Monday.
Guerbet announced that Lipiodol® was approved by the US Food and Drug Administration pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC).
Halozyme Therapeutics, Inc. has announced that the FDA has informed the company that a clinical hold has been placed on patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer.
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa ® (dabigatran etexilate) for the treatment of DVT and PE in patients who have been treated with a parenteral (injectable) anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
One person dies every 36 minutes from an opioid overdose from painkillers. A recently approved drug aims to reverse that trend.
Kaleo announced that the FDA has approved EVZIO (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
The Medicines Company has announced that the FDA has accepted the filing of a biologic license application (BLA) for the investigational hemostatic agent Fibrocaps, a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery, where control of mild or moderate bleeding by conventional means is ineffective or impractical.
The U.S. Food and Drug Administration has approved the first tablet for gradually reducing hay fever allergy symptoms, an alternative to uncomfortable allergy-desensitizing shots.
Tetraphase Pharmaceuticals today announced that the FDA has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company’s lead antibiotic candidate, eravacycline.
MannKind Corporation announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that AFREZZA® (insulin human [rDNA origin]) Inhalation Powder be granted marketing approval by the FDA.
A proposed federal rule that would make it harder for beer breweries to sell leftover grains as animal feed has brewers' blood boiling. Beer makers complain that the new rules, if adopted, would force them to dump millions of tons of "spent grains," which are left over after barley, wheat and other grains are steeped in hot water.
Cubist Pharmaceuticals has announced today that the FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist’s investigational antibiotic SIVEXTRO™ (tedizolid phosphate).
The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group.
Biogen Idec has announced that the FDA has approved ALPROLIX™ [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.
A new class of experimental medicines can dramatically lower cholesterol, raising hopes of a fresh option for people who can't tolerate or don't get enough help from Lipitor and other statin drugs that have been in use for decades.
A South Dakota judge on Thursday refused to throw out a defamation lawsuit against ABC related to its coverage of a meat product called lean, finely textured beef, which critics have dubbed "pink slime."
Twenty-five pharmaceutical companies are voluntarily phasing out the use of antibiotics for growth promotion in animals processed for meat, the Food and Drug Administration said Wednesday.
After months of criticism over its recently launched painkiller Zohydro, the maker of the powerful narcotic is highlighting an unusual oversight board that it's assembled to try and prevent abuse of the drug.
The Race to Yes, a national campaign by families with children facing death from Duchenne Muscular Dystrophy achieved an important milestone just after 8pm EDT last night when the 100,000th person signed their White House petition urging the U.S. Food and Drug Administration to approve a breakthrough drug shown to halt the progress of the disease.
Dermatologists and skin care advocates are frustrated with little to no advances in approval for better sunscreens.
QRxPharma Limited announced today the United States Food and Drug Administration (FDA) has set 22 April 22, 2014 as the date of the Advisory Committee meeting to consider the company's resubmitted Moxduo New Drug Application (NDA).
The FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for patients 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.
The controversy over vaccinations is back in the spotlight, after a Colorado bill passed tightening the loophole that allows parents to choose not to vaccinate, and actress Kristen Cavalarri spoke out against vaccinations claiming a connection with autism. What's more frightening is the frequency of outbreaks of diseases we thought we'd eradicated.
A bill that seeks to allow children with severe epilepsy to legally use oil derived from marijuana advanced Thursday to the South Carolina Senate floor, but with so many restrictions, supporters say it won't help those for whom it's written.
- Page 1