The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for NBI-98854 (Neurocrine Biosciences) for tardive dyskinesia.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to RST-001 for the treatment of retinitis pigmentosa (RP).
AstraZeneca announced that the FDA has approved Xigduo XR (dapagliflozin and metformin HCl extended-release) for adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
Protein Sciences announced that the Food and Drug Administration has approved Flublok (trivalent recombinant hemagglutinin [rHA] influenza vaccine) for all adults aged 18 and older.
The Food and Drug Administration (FDA) has approved Trumenba (Pfizer), the first vaccine approved in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B
The National Institutes of Health (NIH) has announced the launch of a clinical trial to evaluate the effects of aspirin and statins in preventing cardiovascular disease (CVD) in individuals with long-term HIV infections.
The American College of Emergency Physicians (ACEP) has released a second list of their Choosing Wisely recommendations.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).
Pfizer announced that data from a clinical study showed similar sexual function in adults with major depressive disorder (MDD) treated with Pristiq (desvenlafaxine) 50mg and 100mg extended-release tablets daily vs. placebo.
Novo Nordisk announced the launch of NovoFine Plus, their thinnest and shortest pen needles.
Pacira announced results from a study on an Exparel (bupivacaine)-based pain management regimen for reducing postsurgical complications associated with opioid use.
The Food and Drug Administration (FDA) has granted Fast Track status to ARA290 (Araim Pharmaceuticals) for the treatment of Sarcoidosis-associated Small Fiber Neuropathy (SFN).
Patients who are or have taken statins may be at an increased risk of developing herpes zoster.
Kaci Hickox, the nurse who was quarantined outside a New Jersey hospital after returning from working with Doctors Without Borders in West Africa, has been discharged from her mandatory quarantine.
The American College of Emergency Physicians (ACEP) announced that in conjunction with the Centers for Disease Control and Prevention (CDC) and the Emergency Nurses Association, it has established procedures to help emergency personnel evaluate and manage emergency patients suspected of possible Ebola infection.
Octapharma USA announced that Octagam 10% [Immune Globulin Intravenous (Human)] liquid preparation is now available for the treatment of adults with chronic immune thrombocytopenic purpura (ITP).
Children with early-onset asthma who are overweight or obese may mistake exertional dyspnea and esophageal reflux for loss of asthma control, causing them to use more rescue medication.
According to the New York City Health Department, a volunteer medical aid worker who served in Guinea has tested positive for Ebola since his return to the United States.
The FDA is alerting healthcare professionals and emergency responders that certain lots of AtroPen (atropine), CANA (diazepam), morphine sulfate, and pralidoxime chloride auto-injectors manufactured by Meridian Medical Technologies can be used for up to one year beyond the labeled expiration date.
Baxter announced that the FDA has approved Obizur (antihemophilic factor [recombinant], porcine sequence) for the treatment of bleeding episodes in adults with acquired hemophilia A.
Arbor announced that the FDA has approved Sotylize (sotalol HCl) oral solution for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with a history of highly symptomatic atrial fibrillation/flutter.
The fish you eat may be contributing to an increasingly worrisome public health issue: antibiotic resistance.
Endocrine-disrupting chemicals such as bisphenol A (BPA) can be found in many products, even in a restaurant receipt.
Mission Pharmacal announced the launch of CitraNatal basic, an over-the-counter (OTC) prenatal vitamin for pre-pregnancy nutritional support.
What is the best approach to diagnosing and managing acute cystitis in the outpatient setting?
Despite being recalled by the FDA, dietary supplements adulterated with banned substances continue to remain available to the public.
A case study reported in the journal Annals of Pharmacotherapy highlights the use of oral antibiotic therapy for the treatment of Neisseria elongata endocarditis.
The FDA has granted Orphan Drug designation to AC-201 for the treatment of epidermolysis bullosa (EB).
The FDA has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, a once-monthly injectable atypical antipsychotic for the treatment of schizophrenia.
The FDA has accepted for filing the NDA for empagliflozin plus immediate-release metformin HCl fixed-dose combination for the treatment of adults with type 2 diabetes.
Contract Packaging Resources announced a voluntary recall of 11,640 boxes of Assured brand Naproxen Sodium Tablets due to some cartons containing bottles of Ibuprofen.
Takeda and Sunovion announced new data on the short and long-term efficacy, safety, and tolerability of lurasidone (Latuda; Sunovion) in adults with schizophrenia.
Novartis announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has unanimously voted in support of the approval of AIN457 (secukinumab) for the treatment of moderate to severe plaque psoriasis.
Genzyme announced that the Food and Drug Administration (FDA) has approved the inclusion of clinical data from the TOWER and TOPIC studies of Aubagio (teriflunomide).
Auxilium announced that the Food and Drug Administration (FDA) has approved Xiaflex (collagenase clostridium histolyticum) for the treatment of up to 2 Dupuytren's contracture joints in the same hand during a single treatment visit.
Boehringer Ingelheim announced that Ofev (nintedanib) capsules are now available for the treatment of idiopathic pulmonary fibrosis (IPF).
Hospira announced a voluntary recall of 1% Lidocaine HCl for Injection after a confirmed report of human hair in a single unit.
The FDA has accepted for review the Supplemental New Drug Application (sNDA) for Fycompa (perampanel; Eisai) for the treatment of primary generalized tonic-clonic (PGTC) seizures.
The FDA has granted Fast Track designation for trifluridine and tipiracil hydrochloride (TAS-102), an oral combination anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).
Takeda and Orexigen announced that Contrave (naltrexone HCl and bupropion HCl) extended-release tablets are now available by prescription.
The FDA has approved new labeling for Embeda (morphine sulfate and naltrexone HCl; Pfizer) extended-release (ER) capsules to include abuse-deterrence studies.
Regeneron announced results from an effectiveness study sponsored by the National Institutes of Health (NIH) in patients with diabetic macular edema (DME) treated with Eylea (aflibercept) Injection compared to Avastin (bevacizumab; Genentech) and Lucentis (ranibizumab; Genentech).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to OPS202 (OctreoPharm Sciences), an investigational radiotracer, based on a next generation antagonistic somatostatin analog for the management of neuroendocrine tumors.
The Food and Drug Administration has approved Esbriet (pirfenidone; Genentech) and Ofev (nintedanib; Boehringer Ingelheim) for the treatment of idiopathic pulmonary fibrosis (IPF).
Hospira announced a voluntary recall of various lots of several intravenous (IV) solutions in its LifeCare line due to potential for leakage.
A standard prenatal treatment in the United States and other high-income countries for pregnant women at high risk for preterm birth may potentially cause harm if implemented in low-income countries, according to new findings.
Navidea announced that the Food and Drug Administration (FDA) has approved the sNDA for Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and the addition of sentinel lymph node detection for breast cancer and melanoma to the approved indications.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lenvatinib mesylate (Eisai) for the treatment of progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) and granted the NDA Priority Review status.
The Food and Drug Administration (FDA) has granted marketing clearance for the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults with impaired detrusor contractility (IDC).
Orexo AB announced that it has submitted an application to the Food and Drug Administration (FDA) for an expanded label of Zubsolv (buprenorphine/naloxone) sublingual tablet CIII to include initiation of treatment for opioid dependence.
VisionCare Ophthalmic Technologies announced that the Food and Drug Administration (FDA) has approved the Implantable Miniature Telescope for patients with bilateral end-stage age-related macular degeneration (AMD) aged ≥65 years.
The Food and Drug Administration (FDA) has approved Lumason (sulfur hexafluoride lipid microsphere; Bracco Diagnostics) for patients whose echocardiograms are difficult to see with ultrasound waves.
The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the NDA for palbociclib in combination with letrozole, as a first-line treatment of postmenopausal women with ER+, HER- advanced breast cancer who have not received previous systemic treatment for their advanced disease.
The Food and Drug Administration (FDA) has approved Harvoni (ledipasvir/sofosbuvir; Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults ages ≥18.
The Food and Drug Administration (FDA) has approved Lutonix DCB (Lutonix 035 Drug Coated Balloon) Percutaneous Transluminal Angioplasty (PTA) Catheter to re-open arteries in the thigh and knee when narrowed or blocked due to peripheral artery disease (PAD).
New findings from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) indicate significantly better persistency and lower rates of discontinuation therapy with Stelara (ustekinumab; Jannsen Biotech) compared with anti-tumor necrosis factor (TNF)-alpha treatments.
The Food and Drug Administration (FDA) has approved Akynzeo (netupitant and palonosetron; Eisai) to treat nausea and vomiting in patients undergoing cancer chemotherapy.
The conversion of white adipose tissue (WAT) to beige fat as a biological response to cold temperatures may be hindered in overweight individuals, according to a new study published online in the Journal of Clinical Endocrinology & Metabolism.
The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for blinatumomab for the treatment of adults with Philadelphia-negative (PH-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
Strong evidence from a new study in human placenta suggests that Endocrine Disrupting Chemicals (EDCs) can interfere with the action of thyroid hormones in pregnant women.
The Food and Drug Administration (FDA) is advising consumers to not buy or use Sit and Slim II, a product promoted and sold for weight loss.
Millennium: The Takeda Oncology Company, announced that the Food and Drug Administration (FDA) has approved Velcade (bortezomib) for the treatment of mantle cell lymphoma (MCL) in previously untreated patients.
Purdue Pharma announced the launch of a new 7.5mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII, following its Food and Drug Administration (FDA) approval in July 2014.
The Centers for Disease Control and Prevention (CDC) and the Department of Homeland Security's Customs & Border Protection (CBP) will initiate this week, new layers of entry screening in five U.S. airports that receive over 94% of travelers from Ebola-affected nations of Guinea, Liberia, and Sierra Leone.
Hospira announced a voluntary recall of one lot of Vancomycin HCl Injection, equivalent to 1g Vancomycin Sterile Powder because the product may have experienced temperature excursions during shipment.
An experimental avian influenza A H7N9 vaccine prompted immune response in 59% of patients who received two injections at the lowest dosage tested, but only if the vaccine was mixed with an MF59 adjuvant.
Boehringer Ingelheim announced the launch of once-daily Striverdi Respimat (olodaterol) 5mcg inhalation spray for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
The Food and Drug Administration (FDA) has designated lefamulin (Nabriva) as a Qualified Infectious Disease Product (QIDP) and has been granted Fast Track status for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
Amgen announced that its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared to Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.
The Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide; Salix) 2mg rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge.
On September 25, the Food and Drug Administration (FDA) approved two HIV-1 drugs by Gilead: Tybost (cobicistat) and Vitekta (elvitegravir).
The Centers for Disease Control and Prevention (CDC) announced the CDC nowcast model, a new website to help predict the spread of chikungunya in the Americas.
Ferring announced the Food and Drug Administration (FDA) approval of a new cranberry flavor for Prepopik (sodium picosulfate, magnesium oxide, anhydrous citric acid) for oral solution.
The Food and Drug Administration (FDA) has granted Fast Track status to NurOwn (BrainStorm Cell Therapeutics) for the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's Disease).
Eylea (aflibercept) injection has been approved for the treatment of macular edema following retinal vein occlusion (RVO), including macular edema following branch retinal vein occlusion (BRVO) in addition to macular edema following central retinal vein occlusion (CRVO).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to DNX-2401 (DNAtrix), a conditionally-replicative oncolytic adenovirus for malignant glioma.
Omron Healthcare announced the launch of a new line of blood pressure monitors, which obtain five times more data points for a more precise reading.
Bristol-Myers Squibb announced its withdrawal of the New Drug Application (NDA) for asunaprevir for the treatment of patients with hepatitis C virus (HCV) genotype 1b due to the constant change of the HCV treatment landscape in the United States.
Chimerix announced that the Food and Drug Administration (FDA) has granted Emergency Investigational New Drug Applications (EIND) for brincidofovir as potential use in patients infected with the Ebola virus.
Medac Pharma announced the launch of Rasuvo (methotrexate) injection for patients with rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis (pJIA), and psoriasis.
Sagent announced a voluntary nationwide recall of 3 lots of Ketorolac Tromethamine Injection manufactured by Cadila Healthcare Limited.
AbbVie announced that the Food and Drug Administration (FDA) has approved the use of Humira (adalimumab) for moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) to reducing signs and symptoms in patients aged ≥2 years.
Halozyme Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to PEGPH20 (PEGylated recombinant human hyaluronidase) for the treatment of pancreatic cancer.
PediaCare announced the launch of PediaCare SmoothMelts (acetaminophen), their chewable cherry tablets to help reduce fevers and relieve minor aches and pains in children aged 4-11.
The Department of Health and Human Services (HHS) has released its 13th Report on Carcinogens, a document listing chemical, biological, and physical agents that are considered cancer hazards for people living in the United States.
Intarcia Therapeutics announced top-line results from two of its four Phase 3 clinical trials for ITCA 650 (continuously subcutaneous delivery of exenatide) for patients with type 2 diabetes.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AP26113 (ARIAD Pharmaceuticals) for the treatment of anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib.
The Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease.
Qvar with a dose counter (beclomethasone dipropionate HFA; Teva) is now commercially available in the United States.
The Rhode Island Department of Health has confirmed that a Rhode Island child has died due to a Staphylococcus aureus sepsis infection associated with Enterovirus D68 (EV-D68).
Zogenix announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for a modified formulation of Zohydro ER (hydrocodone bitartrate) extended-release capsules.
The Centers for Disease Control and Prevention (CDC) has confirmed the first case of Ebola to be diagnosed in the United States in a male who traveled to Dallas, TX from Liberia.
Ranbaxy announced the launch of Absorica (isotretinoin) 25mg and 35mg capsules for the treatment of severe recalcitrant nodular acne in patients ≥12 years old.
Salix and Progenics announced that the Food and Drug Administration (FDA) has approved Relistor (methylnaltrexone) subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic noncancer pain.
Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has approved Abilify Maintena (aripiprazole) for extended-release injectable suspension as a prefilled dual-chamber syringe.
Avedro announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for riboflavin ophthalmic solution/KXL System for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.
LEO Pharma announced that Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension has been approved for the treatment of plaque psoriasis of the scalp in patients aged 12-17 years.
The United States Department of Health and Human Services announced the development of an investigational drug, AB103, to treat a condition called cytokine storm.
An increase in certain amino acids may be an early sign of pancreatic cancer, occurring before the disease is diagnosed and symptoms appear, reports a new study.
Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma.