Cefaly Technology has received FDA marketing approval for Cefaly, the first TENS device for the preventative treatment of migraine headaches.
Accumulation of esterified cholesterol (cholesteryl ester) in lipid droplets of high-grade prostate cancer (PCa) and PCa metastases may aid in the diagnosis and treatment of advanced disease
Ranbaxy voluntarily recalled 64,626 bottles of Atorvastatin Calcium 10mg Tablets, the generic version of Pfizer's Lipitor.
Sun Pharmaceutical announced a nationwide voluntary recall of 2528 bottles of Metformin HCl Extended-Release Tablets after a customer complaint that some tablets of Gabapentin were found in the bottle.
A novel blood-based biomarker test has been shown to predict with over 90% accuracy the likelihood of a healthy individual developing mild cognitive impairment or Alzheimer's disease within three years.
Elevated urinary levels of the organic compound were found in men with prostate cancer than in those without it.
The FDA has warned consumers that the sexual enhancement supplement Weekend Warrior contains an undisclosed ingredient and should not be purchased or used.
The American Academy of Pain Medicine (AAPM) has issued a position paper warning state and private insurers regarding methadone as a drug of first choice for chronic pain.
The FDA has concluded that compared to the use of imipenem and cilastatin for injection, Doribax carries an increased risk of death and lower clinical cure rates.
Incyte announced results from a Phase 3 trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.
A report by a pharmacist claiming to have found one capsule of Tikosyn (dofetilide) in a bottle of Effexor XR (venlafaxine HCl extended-release) capsules has prompted Pfizer to initiate a recall of three of its products.
Sangamo BioSciences has announced that its genome editing technology has been safely engineered to imitate a naturally occurring genetic mutation that provides resistance to HIV infection.
The FDA has approved Aveed, a unique scheduled injection for the treatment of hypogonadism in adult men.
Baxter announced a voluntary recall of a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose 6000mL (Ambu-Flex II).
The WHO announced the opening of a public consultation regarding their draft guideline on sugar intake.
The FDA has accepted for review an additional sNDA for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept; Navidea) Injection to support broader and more flexible use in imaging and lymphatic mapping procedure.
High concentrations of three common forms of phthalates in men have been shown to impact fertility in couples trying to conceive.
The FDA has issued a Complete Response Letter for the New Drug Application (NDA) of empagliflozin (Boehringer Ingelheim and Eli Lilly and Company) for the reduction of blood glucose levels in adults with type 2 diabetes.
A new study examined how a genetic mutation in untreated patients is linked to aggressive prostate cancer later in life.
Ferumoxytol and iron sucrose have comparable safety in the treatment of anemia in patients with CKD.
Antibiotic prescribing for inpatients is common but offers few benefits and could expose patients to risks for complications like Clostridium difficile if prescribed incorrectly.
Forest Laboratories has submitted a NDA for a fixed-dose combination of memantine HCl extended release and donepezil HCl for the treatment of moderate to severe dementia related to Alzheimer's disease.
Allergy prevalence is uniform across varying regions in the U.S, except in children ≤5 years old, according to an NIH study.
Enanta announced results from the PEARL-III trial studying ABT-450 for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection using a three direct-acting antiviral regimen.
Nonmedical abusers of prescription opioid drugs who have the highest risk of overdose are as likely to obtain them from a friend or family member as a physician's prescription.
Boehringer Ingelheim has announced positive results from several Phase 3 studies on the once-daily tiotropium Respimat inhaler as an add-on treatment for asthma.
Teva announced that Adasuve (loxapine) inhalation powder is now available for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
Genervon was granted an orphan drug designation by the FDA for its bio-drug GM604 (also known as GM6) for the treatment of amyotrophic lateral sclerosis (ALS).
Sunovion and Takeda announced results from a new study evaluating the efficacy and safety of lurasidone (Latuda; Sunovion) in the maintenance treatment of adults with schizophrenia.
The FDA has approved Bydureon Pen (exenatide extended-release for injectable suspension; Bristol-Myers Squibb and AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Bydureon Pen is the first once-weekly treatment for adults with type 2 diabetes.
High intake appears to be especially protective against lethal PCa, data show.
The FDA has granted Orphan Drug designation to Pracinostat (MEI Pharma) for the treatment of acute myeloid leukemia (AML).
High PSA and short PSA double time are associated with a greater likelihood of a positive bone scan.
The Drug Enforcement Administration (DEA) published a proposal to reschedule hydrocodone combination products (HCPs) from Schedule III to Schedule II.
A new device has been shown to provide real-time continuous monitoring of drugs in minute amounts of whole blood.
The FDA has proposed a new format for the Nutrition Facts label for packaged foods to highlight changes in nutrition science and food packaging.
Researchers have discovered a genetic mutation that appears to contribute to a rare but severe form of Cushing's syndrome.
Pacira Pharmaceuticals announced that the Phase 3 trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint.
The FDA has granted Triphase Accelerator's marizomib Orphan Drug designation for the treatment of multiple myeloma.
Forest Labs has announced that it has submitted a New Drug Application (NDA) to the FDA for a once-daily, fixed dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.
Rates for colon cancer screening increased by nearly 40% after complimentary stool kits were mailed to patients' homes, according to a new study.
Anika Therapeutics received FDA marketing approval for Monovisc (sodium hyaluronate [NaHA] in phosphate buffered saline) for the treatment of osteoarthritis (OA) of the knee.
Researchers at the Georgia Institute of Technology have developed a 1.4mm silicon chip that produced three-dimensional real-time images inside the coronary arteries, heart, and peripheral blood vessels.
Children whose mothers took acetaminophen during pregnancy are at a higher risk for developing hyperkinetic disorders (HKDs) and attention-deficit/hyperactivity disorder (ADHD)-like behavioral problems.
The FDA has approved Myalept (metreleptin; Bristol-Myers Squibb) for injection as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy.
Iroko Pharmaceuticals announced that the FDA has approved Tivorbex (indomethacin) capsules for the treatment of mild-to-moderate acute pain in adults.
BD Diagnostics announced that the FDA has granted 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) Waiver for the BD Veritor System for Rapid Detection of Group A Strep.
Onset Dermatologics announced the launch of Minocin (minocycline HCl) 75mg pellet-filled capsules, a new dosage strength for Minocin.
An FDA panel will review information on mitochondrial manipulation to prevent mitochondrial diseases and to treat infertility.
Fresenius Kabi USA announced its launch of Acetylcysteine Solution 20% in 4mL vials for inhalation or oral administration.
Pfizer announced that the FDA has approved a sNDA to update the current label of Xeljanz (tofacitinib citrate) tablets to include radiographic data from two Phase 3 studies, ORAL Scan and ORAL Start.
An NIH study suggests that nearly half of adolescents born with HIV may be at increased risk for cardiovascular disease, including heart attack and stroke.
Results of a recent study showed that an antibody found in the blood of patients with multiple sclerosis (MS) may be present long before the disease and its symptoms appear.
Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial according to patient age in patients with nonvalvular atrial fibrillation (NVAF).
Pfizer announced that the CAPiTA evaluating the efficacy of Prevnar 13 achieved its primary clinical objective and both secondary clinical objectives.
The FDA has accepted Auxilium's supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.
The FDA has granted Bristol-Myers Squibb's DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).
A recent case report examined a polio-like syndrome has been identified in 5 California children over a one-year period.
Novartis has announced that its meningococcal serogroup B (MenB) vaccine will be used at the University of California Santa Barbara (UCSB) as part of a vaccination program.
The FDA has approved a sNDA for Kalydeco (ivacaftor; Vertex) for use in patients with cystic fibrosis (CF) ages >6 years old who have 1 of 8 additional mutations in the CF transmembrane conductance regulator (CFTR) gene.
Janssen R&D has announced the initiation of the Phase 3 CREDENCE trial, which will examine if the use of Invokana (canagliflozin) can slow the progression of diabetic nephropathy in patients with type 2 diabetes.
The FDA has designated SCY-078 (Scynexis) Qualified Infectious Disease Product (QDIP) for invasive Candidiasis, including Candidemia, and Aspergillosis.
The American Society of Addiction Medicine (ASAM) has issued their Standards of Care for the Addiction Specialist Physician for physicians caring for patients with addiction and related disorders.
According to the CDC's Morbidity and Mortality Weekly Report, younger- and middle-aged adults were hit particularly hard this influenza season.
The NIH has identified gene variants that cause a rare syndrome, appearing in early childhood.
Bayer HealthCare announced that it has begun enrolling patients into the Phase 3 COAST trial studying Stivarga (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases.
A new non-surgical medical device is currently undergoing clinical trials in the U.S. for the treatment of type 2 diabetes in patients who are also trying to lose weight.
The FDA has granted Orphan Drug Status for the use of UPI-928 (Update Pharma) for the treatment of Acute Myeloid Leukemia (AML).
The FDA has granted accelerated approval of Northera (droxidopa; Chelsea Therapeutics) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH).
The FDA announced the approval of Vimizim (elosulfase alfa; BioMarin) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome).
Teva announced the launch of Nuvigil (armodafinil) 200mg tablets, a new dosage strength for Nuvigil.