NBI-98854 Designated Breakthrough Therapy for Tardive Dyskinesia

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for NBI-98854 (Neurocrine Biosciences) for tardive dyskinesia.

Investigational Gene Therapy Designated Orphan Drug for Eye Disorder

The Food and Drug Administration (FDA) has granted Orphan Drug designation to RST-001 for the treatment of retinitis pigmentosa (RP).

Xigduo XR Approved for Type 2 Diabetes

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.

Flublok Now Approved for Use in All Adults

Flublok Now Approved for Use in All Adults

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.

First Meningococcal B Vaccine Approved by FDA

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

Study: Can Aspirin, Statins Prevent CVD in HIV Patients?

Study: Can Aspirin, Statins Prevent CVD in HIV Patients?

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.

Emergency Docs Issue Additional Choosing Wisely Recommendations

The American College of Emergency Physicians (ACEP) has released a second list of their Choosing Wisely recommendations.

Glassia Designated Orphan Drug for Graft-Versus-Host Disease

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).

Pristiq Shows Low Chance of Sexual Dysfunction in Adults with MDD

Pristiq Shows Low Chance of Sexual Dysfunction in Adults with MDD

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.

New Ultra-Short, Ultra-Thin Pen Needles Launched by Novo Nordisk

Novo Nordisk announced the launch of NovoFine Plus, their thinnest and shortest pen needles.

Exparel Reduces Postsurgical Complications with Opioid Use

Exparel Reduces Postsurgical Complications with Opioid Use

Pacira announced results from a study on an Exparel (bupivacaine)-based pain management regimen for reducing postsurgical complications associated with opioid use.

Sarcoidosis-Associated Small Fiber Neuropathy Therapy Fast Tracked by FDA

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).

Are Statin-Users at Greater Risk for Herpes Zoster?

Patients who are or have taken statins may be at an increased risk of developing herpes zoster.

NY, NJ Ignite Debate on Ebola Quarantine Policies in U.S.

NY, NJ Ignite Debate on Ebola Quarantine Policies in U.S.

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.

New Guidelines for Managing Emergency Patients Suspected of Ebola Infection

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.

Octagam 10% Now Available for Chronic Immune Thrombocytopenic Purpura

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).

Overweight Children More Likely to Report Worse Asthma Control

Overweight Children More Likely to Report Worse Asthma Control

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.

First Ebola Case Confirmed in NYC

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.

FDA: Certain Auto-Injectors OK to Use 1 Year Beyond Exp Date

FDA: Certain Auto-Injectors OK to Use 1 Year Beyond Exp Date

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.

Obizur Approved for Acquired Hemophilia A

Obizur Approved for Acquired Hemophilia A

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.

Antiarrhythmic Agent Sotylize Gets FDA Approval

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.

Are Fish Contributing to Antibiotic Resistance?

Are Fish Contributing to Antibiotic Resistance?

The fish you eat may be contributing to an increasingly worrisome public health issue: antibiotic resistance.

Hand Sanitizer + Restaurant Receipt Could Add Up to More BPA in the Body

Hand Sanitizer + Restaurant Receipt Could Add Up to More BPA in the Body

Endocrine-disrupting chemicals such as bisphenol A (BPA) can be found in many products, even in a restaurant receipt.

CitraNatal Basic, OTC Pre-Pregnancy Supplement Launched

CitraNatal Basic, OTC Pre-Pregnancy Supplement Launched

Mission Pharmacal announced the launch of CitraNatal basic, an over-the-counter (OTC) prenatal vitamin for pre-pregnancy nutritional support.

Treating UTI in the Outpatient Setting

Treating UTI in the Outpatient Setting

What is the best approach to diagnosing and managing acute cystitis in the outpatient setting?

Despite FDA Recalls, Banned Dietary Supplements Remain for Sale

Despite being recalled by the FDA, dietary supplements adulterated with banned substances continue to remain available to the public.

Case Study: Oral Antibiotic Tx for Endocarditis

A case study reported in the journal Annals of Pharmacotherapy highlights the use of oral antibiotic therapy for the treatment of Neisseria elongata endocarditis.

Rare Skin Disorder Therapy Granted Orphan Drug Designation

The FDA has granted Orphan Drug designation to AC-201 for the treatment of epidermolysis bullosa (EB).

FDA to Review Aripiprazole Lauroxil NDA for Schizophrenia

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.

FDA Accepts NDA for Type 2 Diabetes Combo Drug for Filing

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.

Over 11,000 Boxes of Naproxen Recalled Due to Drug Mix-up

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.

New Data on Latuda for Schizophrenia Announced

New Data on Latuda for Schizophrenia Announced

Takeda and Sunovion announced new data on the short and long-term efficacy, safety, and tolerability of lurasidone (Latuda; Sunovion) in adults with schizophrenia.

Novel Psoriasis Drug Recommended by FDA Advisory Group

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.

More Safety, Efficacy Data for MS Drug Aubagio

More Safety, Efficacy Data for MS Drug Aubagio

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).

Xiaflex Gains Expanded Dupuytren's Contracture Use

Xiaflex Gains Expanded Dupuytren's Contracture Use

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.

Ofev Launched for Idiopathic Pulmonary Fibrosis

Ofev Launched for Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim announced that Ofev (nintedanib) capsules are now available for the treatment of idiopathic pulmonary fibrosis (IPF).

Hospira Recalls Lidocaine HCl for Injection

Hospira announced a voluntary recall of 1% Lidocaine HCl for Injection after a confirmed report of human hair in a single unit.

Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures

Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures

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.

FDA Fast Tracks Combination Metastatic Colorectal Cancer Drug

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).

Contrave Now Available for Chronic Weight Management

Takeda and Orexigen announced that Contrave (naltrexone HCl and bupropion HCl) extended-release tablets are now available by prescription.

First ER Morphine Designed to Deter Abuse When Crushed

The FDA has approved new labeling for Embeda (morphine sulfate and naltrexone HCl; Pfizer) extended-release (ER) capsules to include abuse-deterrence studies.

Eylea Shows Greater Visual Acuity Gain in DME Trial

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).

Investigational Radiotracer Designated Orphan Drug for Neuroendocrine Tumors

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.

Two New Drugs for Idiopathic Pulmonary Fibrosis Approved

The Food and Drug Administration has approved Esbriet (pirfenidone; Genentech) and Ofev (nintedanib; Boehringer Ingelheim) for the treatment of idiopathic pulmonary fibrosis (IPF).

Possible Leak with Certain LifeCare IV Solutions

Hospira announced a voluntary recall of various lots of several intravenous (IV) solutions in its LifeCare line due to potential for leakage.

Preterm Birth Therapy May Not Be Effective Everywhere

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.

Lymphoseek Gains Expanded Diagnostic Indications

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.

Lenvatinib NDA Under Review for RAI-Refractory Differentiated Thyroid Cancer

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.

Replaceable Urinary Prosthesis For Women Cleared by FDA

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 Seeks to Expand Zubsolv Labeling

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.

Mini Telescope Implant for AMD Use Expanded

Mini Telescope Implant for AMD Use Expanded

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.

Lumason Approved for ECG Enhancement

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.

Palbociclib + Letrozole NDA Under Review for Advanced Breast Cancer

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.

First Once-Daily Single Combo Tablet for HCV Genotype 1 Approved

First Once-Daily Single Combo Tablet for HCV Genotype 1 Approved

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.

FDA OK's Drug-Coated Balloon PTA Catheter for PAD

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).

Stelara: Better Persistency, Lower Discontinuation Rates in Psoriasis Study

Stelara: Better Persistency, Lower Discontinuation Rates in Psoriasis Study

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.

Akynzeo Approved for Chemotherapy-Induced Nausea, Vomiting

The Food and Drug Administration (FDA) has approved Akynzeo (netupitant and palonosetron; Eisai) to treat nausea and vomiting in patients undergoing cancer chemotherapy.

Obesity May Hinder "Good Fat" Conversion in Cold Months

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.

Blinatumomab BLA to be Reviewed for Acute Lymphoblastic Leukemia

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).

Harmful Chemicals May Penetrate Placenta During Pregnancy, Impact Thyroid Hormones

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.

Hidden Ingredients Discovered in Sit and Slim II

Hidden Ingredients Discovered in Sit and Slim II

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.

New Velcade Indication Approved in Mantle Cell Lymphoma

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.

New Dosage Strength of Butrans Launched

New Dosage Strength of Butrans Launched

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.

CDC, CBP Initiate Ebola Screenings at Five Major Airports

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.

Temperature Excursions Lead to Vancomycin Injection Recall

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.

Experimental Bird Flu Vaccine More Effective with Adjuvant

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.

Striverdi Respimat Now Available for COPD

Striverdi Respimat Now Available for COPD

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.

Lefamulin Designated QIDP and Fast Track Status for Bacterial Infections

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).

Adalimumab Biosimilar Meets Endpoint in Plaque Psoriasis Study

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.

Final Approval of Uceris Rectal Foam for Ulcerative Colitis Granted by FDA

Final Approval of Uceris Rectal Foam for Ulcerative Colitis Granted by FDA

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.

Two New HIV-1 Drugs Get FDA Approval

On September 25, the Food and Drug Administration (FDA) approved two HIV-1 drugs by Gilead: Tybost (cobicistat) and Vitekta (elvitegravir).

Chikungunya Prediction Model Announced by the CDC

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.

Prepopik Gains Approval for New Cranberry Flavor

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.

NurOwn Granted Fast Track Status for ALS

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 Gains Expanded Macular Edema Indication

Eylea Gains Expanded Macular Edema Indication

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).

Oncolytic Adenovirus Designated Orphan Drug for Malignant Glioma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DNX-2401 (DNAtrix), a conditionally-replicative oncolytic adenovirus for malignant glioma.

Omron Launches New Line of Advanced BP Monitors

Omron Launches New Line of Advanced BP Monitors

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.

BMS Will No Longer Pursue Asunaprevir Approval

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.

Investigational Ebola Drug Granted Emergency INDs

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.

Rasuvo Autoinjector Launched for RA, pJIA, Psoriasis

Rasuvo Autoinjector Launched for RA, pJIA, Psoriasis

Medac Pharma announced the launch of Rasuvo (methotrexate) injection for patients with rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis (pJIA), and psoriasis.

Recall Due to Wrong Exp Date on Ketorolac Label

Sagent announced a voluntary nationwide recall of 3 lots of Ketorolac Tromethamine Injection manufactured by Cadila Healthcare Limited.

FDA Expands Humira Use for pJIA in Children Aged 2 Years and Up

FDA Expands Humira Use for pJIA in Children Aged 2 Years and Up

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.

PEGPH20 Designated Orphan Drug for Pancreatic Cancer

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 Smooth Melts for Fever, Pain Relief Launched

PediaCare Smooth Melts for Fever, Pain Relief Launched

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.

HHS Carcinogen Report Includes Three New Substances

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.

Investigational Pump Efficacious in Type 2 Diabetes Trials

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.

ALK+ Metastatic NSCLC Therapy Designated Breakthrough Therapy

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.

Investigational Sickle Cell Disease Agent Fast Tracked

The Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease.

Qvar with Dose Counter Now Available

Qvar with a dose counter (beclomethasone dipropionate HFA; Teva) is now commercially available in the United States.

Child Dies from Enterovirus-Related Infection in RI

Child Dies from Enterovirus-Related Infection in RI

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).

New Zohydro ER Formulation sNDA Submitted to FDA

New Zohydro ER Formulation sNDA Submitted to FDA

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.

First Ebola Case Diagnosed in U.S., Reports CDC

First Ebola Case Diagnosed in U.S., Reports CDC

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.

Absorica Caps Launched in Two New Strengths

Ranbaxy announced the launch of Absorica (isotretinoin) 25mg and 35mg capsules for the treatment of severe recalcitrant nodular acne in patients ≥12 years old.

Relistor Approved for Opioid-Induced Constipation in Chronic Noncancer Pain Patients

Relistor Approved for Opioid-Induced Constipation in Chronic Noncancer Pain Patients

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.

FDA Approves New Formulation for Abilify Maintena

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 Resubmits NDA for Eye Disorders

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.

Scalp Plaque Psoriasis Tx Approved for Pediatric Patients

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.

HHS to Fund Novel Drug for Cytokine Storm Prevention

The United States Department of Health and Human Services announced the development of an investigational drug, AB103, to treat a condition called cytokine storm.

Amino Acids May Be Early Marker of Pancreatic Cancer

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.

Adcetris Extends Survival in Post-Transplant Hodgkin Lymphoma Study

Seattle Genetics and Takeda announced results from the Phase 3 AETHERA trial with Adcetris (brentuximab vedotin) in patients with post-transplant Hodgkin lymphoma.

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