The FDA is alerting healthcare professionals and consumers of a voluntary recall of all non-expired drug products for sterile use by Unique Pharmaceuticals, as they may be contaminated.
Boehringer Ingelheim has issued a statement regarding a recent article published in BMJ on the use of Pradaxa (dabigatran etexilate mesylate) and monitoring of anticoagulant activity and plasma levels.
Reports of lifetime use of synthetic human growth hormone (hGH) without a prescription has more than doubled since 2012 among teens, while alcohol consumption has significantly decreased and marijuana use has remained steady, states a new study from the Partnership for Drug-Free Kids.
The FDA has approved Zydelig (idelalisib; Gilead Sciences) for relapsed chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL), and small lymphocytic lymphoma (SLL).
United Therapeutics announced a voluntary recall of the medical devices Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A due to incorrect software programming.
Eagle Pharmaceuticals announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension, an antidote for the management of malignant hyperthermia (MH), along with the appropriate supportive measures.
The FDA has designated Recombinant Human Nerve Growth Factor (rhNGF; Dompe) Orphan Drug status for the treatment of neurotrophic keratitis.
Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.
The FDA is warning consumers not to purchase or use O.M.G., a product marketed for sexual enhancement.
Researchers have unmasked 108 chromosomal sites harboring inherited variations in the genetic code linked to schizophrenia, of which 83 have never been reported before in the largest genomic dragnet of any psychiatric disorder to date.
The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.
Sanofi Pasteur has announced that the first lots of Fluzone (Influenza vaccine) for the 2014-2015 season have been shipped.
The FDA has designated Fast Track status to SAGE-547 (SAGE Therapeutics) for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.
BioAlliance Pharma announced the launch of Sitavig (acyclovir) in the U.S. by Innocutis Holdings LCC for the treatment of recurring Herpes labialis.
New research has found that the majority of the genetic risk for autism is due to a common genetic variation, rather than rare or spontaneous mutations.
The FDA is advising healthcare professionals and consumers against the use of drugs marketed as sterile by Downing Labs LLC, also known as NuVision Pharmacy in Dallas, TX, as they may be contaminated.
American Health Packaging announced a voluntary recall of Ibuprofen Tablets 600mg and Oxcarbazepine Tables 300mg due to mislabeled inner unit dose blister packaging.
The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.
The FedEx Corporation has been indicted with charges relating to conspiracies with two separate but related online pharmacy organizations to distribute misbranded prescription drugs and controlled substances to U.S. consumers without requiring a valid prescription.
Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.
Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (afilbercept) injection for the treatment of diabetic macular edema (DME).
Shire announced top-line results from two Phase 4 efficacy and safety studies of Vyvanse (lisdexamfetamine dimesylate) compared to Concerta (methylphenidate HCl) in patients with Attention Deficit Hyperactivity Disorder (ADHD).
Libertas Pharma announced the launch of Multivitamins with A, B, D, E and K plus Zinc in three different formulations for patients with malabsorptive conditions, including cystic fibrosis.
The FDA has designated isavuconazole (Astellas) as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis.
The FDA has issued an update regarding the discovery of vials containing the smallpox virus in a FDA storage room on July 1, 2014.
Salix and Pharming Group NV announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE).
Baxter announced a voluntary recall of one lot of highly concentrated Potassium Chloride Injection 20mEq/50mL in a ViaFlex Container and three lots of 0.9% Sodium Chloride Injection due to particulate matter, found in the solutions.
The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).
Purdue Pharma announced that it has received FDA approval for a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII and the use of two patches to facilitate dose adjustments during titration, with a total max dose from both patches of 20mcg/hour.
Pfizer announced positive results of a Phase 3 study comparing BeneFIX Coagulation Factor IX (Recombinant) to on-demand treatment in patients with moderately severe to severe hemophilia B.
The FDA has designated Priority Review to the supplemental New Drug Application (sNDA) for Olysio (simeprevir) in combination with sofosbuvir for 12 weeks of treatment in adults with genotype 1 chronic hepatitis C.
The FDA has accepted for review Pozen's resubmitted New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.
The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)] liquid preparation for the treatment of adults with chronic immune thrombocytopenic purpura (ITP).
The FDA has accepted Genentech's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.
Neos Therapeutics announced the completion of a positive Phase 3 study for its investigational methylphenidate XR-ODT (NT-0102) drug candidate in children with Attention Deficit/Hyperactivity Disorder (ADHD).
The FDA has accepted for review Teva's New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) both in patients ≥12 years of age.
The FDA has accepted for review the New Drug Application (NDA) for Toujeo (insulin glargine [rDNDA origin]; Sanofi) injection, an investigational basal insulin.
Genetic markers associated with eosinophilic esophagitis (EoE) have been identified, suggesting that several genes are involved in the development of EoE.
Otsuka and Lundbeck announced the submission of a New Drug Application (NDA) to the FDA for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).
The FDA is alerting healthcare professionals not to use drugs marketed as sterile by Unique Pharmaceuticals as they may be contaminated.
Janssen submitted a supplemental New Drug Application (sNDA) to the FDA for a label change to include new data demonstrating significantly delayed time to relapse in patients taking Invega Sustenna (paliperidone palmitate) compared to other selected oral antipsychotics for the treatment of schizophrenia.
Medac Pharma announced that the FDA has approved Rasuvo (methotrexate) subcutaneous auto-injector for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.
Genentech announced results from coBRIM, a Phase 3 trial evaluating cobimetinib in combination with Zelboraf (vemurafenib) in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAFV600 mutation.
The CDC released a report reviewing the incident in June that involved the unintentional exposure of potentially viable anthrax at the CDC's Roybal Campus.
Hospira announced a voluntary nationwide recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000mL, Flexible Container.
For the first time, the WHO is strongly recommending that men who have sex with men (MSM) consider pre-exposure prophylaxis for the prevention of HIV infection in addition to the use of condoms.
The Drug Enforcement Administration (DEA) has officially declared tramadol as a Class IV substance.
The Defense Advanced Research Projects Agency (DARPA) announced that two universities will lead the agency's Restoring Active Memory (RAM) program to develop and test wireless, implantable devices to restore memory incurred due to traumatic brain injury (TBI) or disease.
Astellas has submitted a New Drug Application (NDA) to the FDA for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.
Novartis announced results from two Phase 3 trials evaluating secukinumab in patients with moderate-to-severe plaque psoriasis.
Kaléo, Inc. announced that Evzio (naloxone HCl injection) auto-injector is now commercially available for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or CNS depression.
Researchers at The Cancer Genome Atlas (TCGA) Research Network have identified genetic mutations in the cell signaling pathway RTK/RAS/RAF that can lead to lung adenocarcinoma, the most common subtype of lung cancer.
Monistat announced the launch of Monistat Complete Care products, which include a vaginal health test, probiotics, and an odor-neutralizing gel.
The FDA is warning consumers to not buy or use 6 supplements that are promoted for weight loss.
PuraCap announced the introduction of EpiCeram Airless Pump, the latest addition to the EpiCeram line.
A new study funded by the National Eye Institute (NEI) has found that behavior activation and low-vision occupational therapy can reduce the risk of depression by 50% in patients with age-related macular degeneration (AMD).
Scientists of the National Institutes of Health (NIH) found vials labeled "variola" in an unused portion of a storage room in a FDA laboratory on the NIH Bethesda campus.
Adults with extreme obesity have increased risks of dying at a young age from cancer and other conditions, including heart disease, stroke, diabetes, and kidney and liver diseases, according to results of a pooled analysis.
Protein Sciences announced that the FDA has approved the strain change amendment for its 2014/15 seasonal influenza vaccine, Flublok.
Otonomy announced positive results from two Phase 3 trials of AuriPro (ciprofloxacin) for intra-operative treatment of middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.
Sunovion announced data from a one-year study on the risk of respiratory death or chronic obstructive pulmonary disease (COPD) exacerbation-related hospitalization in patients taking arformoterol tartrate (Brovana).
The FDA has granted Orphan Drug designation to bendamustine HCl (Eagle Pharmaceuticals) for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL).
The FDA has granted Priority Review designation to hydrocodone bitartrate tablets (HYD), an investigational once-daily pain medication.
NeuroMetrix announced that it has received FDA premarket clearance for its wearable technology for the treatment of chronic pain.
Anacor announced that the FDA has approved Kerydin (tavaborole) 5% topical solution for the treatment of onychomycosis of the toenails.
The FDA announced the approval of NovoSeven RT for the treatment of patients with refractory Glanzmann's Thrombasthenia (GT).
CASI Pharmaceuticals announced that the FDA has granted Orphan Drug designation to ENMD-2076 for the treatment of hepatocellular carcinoma (HCC).
New research has found a genetic identifier for autism that includes physical features that may eventually allow clinicians to identify babies at risk for autism before they are born.
The FDA has approved Beleodaq (belinostat; Spectrum Pharmaceuticals) for the treatment of patients with peripheral T-cell lymphoma (PTCL).
Novartis announced that it has begun shipment of its seasonal influenza vaccines for the 2014-2015 season, with a minimum shipment of 30 million doses of the Influenza Virus Vaccines Flucelvax and Fluvirin prior to the influenza season peak.
EarlySense has announced that the FDA has issued clearance for the Chair Sensor Solution, the first automatic contact-free sensor for continuous monitoring of patients' vital signs in a chair.
The FDA has accepted for filing and granted priority review designation to Boehringer Ingelheim's New Drug Application (NDA) for nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).
The CDC's Vital Report evaluated prescribing rates by state for various types of opioid painkillers, long-acting/extended-release (LA/ER) opioid painkillers, high-dose opioid painkillers, and benzodiazepines.
The most recent data from the Centers for Disease Control and Prevention (CDC) shows that while multi-drug resistant foodborne Salmonella decreased during the past 10 years and drug resistance remained low in 2012, resistance in the germ that causes typhoid fever to quinolone drugs increased significantly in 2012.
Bristol-Myers Squibb announced a voluntary recall of 6 lots of Coumadin for Injection, 5mg single-use vials, in the U.S.
Synageva BioPharma announced that the Phase 3 ARISE trial of sebelipase alfa in patients with lysosomal acid lipase deficiency (LAL Deficiency) met the primary endpoint.
The FDA has granted Breakthrough Therapy designation to blinatumomab for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
Ipsen Biopharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Salix announced results from the Phase 3 TARGET 3 trial evaluating the use of repeat treatment with rifaximin 550mg in patients with irritable bowel syndrome with diarrhea (IBS-D).
Even at lower levels, blood lead concentrations have been linked to an increased risk of behavioral problems in preschool children, including internalizing and pervasive developmental problems.
The FDA is alerting healthcare professionals not to use injectable vitamin products distributed by Medical Supply Liquidators LLC in Clive, IA, with "Sunshine Labs" on the label.
SteriWeb Medical announced that it has received FDA over-the-counter (OTC) clearance for Omnicide Antimicrobial Gel, a long-lasting non-antibiotic petroleum-based topical gel for the treatment and prevention of bacterial infections and protection of the affected area.
Aqua Pharmaceuticals announced the launch of Cordran Ointment (flurandrenolide) 0.05% for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
A new supercooling technique to increase the amount of time that organs can remain viable outside of the body has succeeded in clinical trials involving rats, and could improve transplantation outcomes in humans.
Merck announced results from a Phase 3 Emend (aprepitant) study in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.
NPS Pharmaceuticals announced that the FDA has approved updated labeling for Gattex (teduglutide [rDNA origin]) for injection to include long-term data from the STEPS 2 study of adult patients with short bowel syndrome.
Upsher-Smith announced the launch of Qudexy XR (topiramate) extended-release capsules.
The FDA announced the approval of Afrezza (insulin human; MannKind) Inhalation Powder for the improvement of glycemic control in adults with diabetes mellitus.
The FDA has cleared the first motorized device intended to act as an exoskeleton in individuals with paraplegia due to spinal cord injuries for use at home and in the community.
Telemedicine is a valid means of screening for retinopathy of prematurity (ROP), reports a new study in JAMA Ophthalmology.
The Centers for Disease Control and Prevention (CDC) has released updated recommendations on laboratory testing for diagnosing HIV infection in patients >24 months of age.
The FDA has issued a warning that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain, and that OTC topical medications may also be harmful and should not be used.
A medical practice in KY has pleaded guilty to federal charges regarding the purchasing and selling of unapproved and improperly labeled chemotherapy drugs.
The FDA has granted Breakthrough Therapy designation to idarucizumab (Boehringer Ingelheim), an investigational fully humanized antibody fragment (Fab), being evaluated as a specific antidote for Pradaxa (dabigatran etexilate mesylate).
The FDA has issued a warning that certain over-the-counter (OTC) topical acne medications may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.
The FDA has announced a nationwide recall of over 13,000 bottles of Dr. Reddy's Laboratories' Metoprolol Succinate Extended-Release Tablets,
Quest Products announced the launch of ProVent Eczema and Psoriasis Spray indicated to help minimize the appearance of skin conditions often associated with eczema and psoriasis.
Bristol-Myers Squibb's Phase 3 study, CheckMate -066 evaluating nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early due to an analysis demonstrating evidence of superior overall survival in patients receiving nivolumab compared to the control arm.
Doctor's Best announced a voluntary nationwide recall of over 7,000 bottles of Red Yeast Rice dietary supplements 600mg capsules used to lower cholesterol.