Plecanatide Shows Promise for Treating IBS With Constipation

By December 09, 2016

Synergy has announced results from the first two pivotal Phase 3 trials evaluating plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).

Investigational Alzheimer's Drug Shows Efficacy for Specific Gene Carriers

By December 09, 2016

Alzheon has presented new analyses of a Phase 3 trial of tramiprosate, a potential Alzheimer's disease (AD) treatment.

FDA to Review Combo Drug Considered a Salvage Therapy for HCV Patients

By December 08, 2016

Gilead Sciences announced the submission of a New Drug Application (NDA) for a once-daily single tablet regimen containing sofosbuvir 400mg, velpatasvir 100mg, and voxilaprevir 100mg (SOF/VEL/VOX) for the treatment of patients with direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV) infection.

Study Shows Direct Switch to Ultibro Breezhaler Improves COPD Symptoms

By December 08, 2016

Novartis announced positive data from the CRYSTAL study evaluating the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate chronic obstructive pulmonary disease (COPD) from their current treatments to Ultibro Breezhaler (indacaterol/glycopyrronium) 110mcg/50mcg.

Cimzia Effectiveness Assessed for Chronic Plaque Psoriasis

By December 08, 2016

UCB and Dermira have announced topline results from their Phase 3 trial (CIMPASI-1) evaluating the safety and efficacy of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis.

Efficacy Results Announced for Combo Psoriasis Therapy

By December 08, 2016

Valeant announced positive results from a Phase 3 study of IDP-118 (halobetasol propionate and tazarotene lotion) in the treatment of plaque psoriasis.

Fast Track Designation Granted to Novel Gastroparesis Therapy

By December 06, 2016

Theravance announced that the Food and Drug Administration (FDA) has granted Fast Track designation to to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.

T2DM Drug Semaglutide Gets Closer to Approval with NDA Submission

By December 05, 2016

Novo Nordisk has announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for semaglutide, for the treatment of adults with type 2 diabetes.

FDA Accepts Keytruda sBLA for Hodgkin Lymphoma Indication

By December 01, 2016

Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review.

Drug to Prevent S. aureus Pneumonia Gets Fast Track Designation

By December 01, 2016

Arsanis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to ASN100, a novel combination of two fully human monoclonal antibodies to potentially prevent Staphylococcus aureus pneumonia.

DS-8201 Fast-Tracked for HER2+ Metastatic Breast Cancer

By December 01, 2016

Daiichi Sankyo announced that the Food and Drug Administration (FDA) has granted Fast Track designation for DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

Significant Seizure Reduction with Pregabalin in Pediatric Study

By December 01, 2016

Pfizer announced positive Phase 3 study data that evaluated Lyrica (pregabalin) capsules and oral solution as adjunctive therapy for pediatric epilepsy patients aged 4-16 years with partial onset seizures.

Pediatric Crohn's Disease Therapy Granted Orphan Drug Designation

By November 30, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066) for the investigational treatment of Crohn's disease in pediatric patients.

Priority Review Given to Metastatic Merkel Cell Carcinoma Agent

By November 30, 2016

Merck and Pfizer announced that the Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab to treat metastatic Merkel cell carcinoma.

Promising Results for Breast Cancer Drug Biosimilar

By November 30, 2016

Pfizer announced positive results from the REFLECTIONS B3271002 study that compared the safety and efficacy of Herceptin (trastuzumab; Genentech) and PF-05280014, a potential biosimilar to Herceptin.

FDA to Review Abilify Maintena for Bipolar I Disorder

By November 30, 2016

Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena (aripiprazole extended-release) for the maintenance treatment of bipolar I disorder in adults.

Biosimilar Candidate Effective in Phase 3 Psoriasis Trial

By November 29, 2016

Momenta has announced their adalimumab biosimilar candidate, M923, has met its Phase 3 primary endpoint of at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.

Results Released for Investigational Uveitis Therapy

By November 29, 2016

Santen has announced positive results from two Phase 3 trials of sirolimus intravitreal injection 440µg (Opsiria) for patients with non-infectious uveitis of the posterior segment.

Rare Liver Disorder Therapy Designated Orphan Drug

By November 28, 2016

PhaseRx announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for PRX-OTC for the treatment of ornithine transcarbamylase deficiency (OTCD).

Novel Opioid Therapy Emits Blue Dye as Abuse Indicator

By November 28, 2016

Intellipharmaceutics has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for Rexista, a formulation of extended-release oxycodone hydrochloride with abuse-deterrent properties.

Results for Solanezumab in Mild Dementia of Alzheimer's Disease Announced

By November 23, 2016

Eli Lilly announced that solanezumab did not meet the primary endpoint in the Phase 3 EXPEDITION3 clinical trial in patients with mild dementia due to Alzheimer's disease.

Unique Diabetes Therapy Moves One Step Closer to Approval

By November 21, 2016

Intarcia has submitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for ITCA 650, a novel, subcutaneous GLP-1 receptor agonist therapy for the treatment of type 2 diabetes (T2D).

Company Halts Development of Post-Stroke Walking Difficulty Therapy

By November 21, 2016

Acorda has stopped development of dalfampridine to treat post-stroke walking difficulties (PSWD), due to an overall lack of clinically meaningful efficacy.

FDA to Review Closed Triple Combo Tx for COPD

By November 21, 2016

GlaxoSmithKline (GSK) and Innoviva have announced GSK's New Drug Application submission to the Food and Drug Administration (FDA) for the once-daily, closed triple combo therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25mcg), for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

FDA to Review Investigational Plaque Psoriasis Treatment

By November 17, 2016

Janssen has announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA), seeking approval of guselkumab for the treatment of adults with moderate to severe plaque psoriasis.

FDA Grants Orphan Drug Status to Novel PAH Treatment

By November 17, 2016

Reviva announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for RP5063, its lead development product for the treatment of pulmonary arterial hypertension (PAH).

Novel BACE Inhibitor in Development for Alzheimer's Disease

By November 17, 2016

Eisai announced that the Food and Drug Administration (FDA) has granted Fast Track designation for E2609 (Eisai and Biogen) in development for early Alzheimer's disease.

Positive Results Announced for Seborrheic Keratosis Treatment

By November 16, 2016

Aclaris has announced positive results from its two pivotal Phase 3 trials of A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK).

Treatment for Painful Foot Nerve Disorder Gets Fast Track Designation

By November 15, 2016

Centrexion announced that the Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975, a novel therapy intended to treat Morton's neuroma.

Phase 3 Trial Shows Promise in Treating Multi-Drug Resistant HIV-1

By November 10, 2016

TaiMed Biologics have released positive preliminary results of the Phase 3 trial of ibalizumab in patients with multi-drug resistant (MDR) HIV-1 (TMB-301).

FDA to Review Novel Sickle Cell Disease Therapy

By November 09, 2016

Emmaus Life Sciences has announced that the Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.

Trastuzumab Biosimilar BLA Submitted to FDA

By November 08, 2016

Mylan and Biocon announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for MYL-141O, the proposed biosimilar to trastuzumab.

Novel Mucopolysaccharidosis Tx Designated Orphan Drug

By November 07, 2016

Eloxx announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ELX-02, its propriety drug candidate for the treatment of mucopolysaccharidosis type 1 (MPS I).

Spinraza Improves Motor Function in Spinal Muscular Atrophy Study

By November 07, 2016

Biogen and Ionis have announced positive results from the Phase 3 study of Spinraza (nusinersen), an investigational treatment for spinal muscular atrophy (SMA) in children.

PARP Inhibitor Veliparib Gets Orphan Drug Status from FDA

By November 04, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an investigational combination with chemotherapies or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).

Investigational Insomnia Treatment Improves Sleep in Pediatric Patients

By November 02, 2016

Neurim announced positive top-line results from its NEU_CH_7911 Phase 3 study evaluating the efficacy and safety of PedPRM, a novel treatment for pediatric insomnia, designed for those with swallowing difficulties.

Positive Results for On-Demand Hypoactive Sexual Desire Disorder Drug

By November 02, 2016

Palatin has announced positive top-line results from the Phase 3 clinical trial of bremelanotide (a melanocortin 4 receptor agonist), an investigational treatment for hypoactive sexual desire disorder (HSDD).

Brigatinib NDA Accepted for FDA Review

By October 31, 2016

ARIAD announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for brigatinib to treat patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who have progressed on crizotinib.

FDA to Review Treatment for Levodopa-Induced Dyskinesia

By October 27, 2016

Adamas announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, to potentially treat levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

NDA Submitted for Extended-Duration VTE Prophylaxis Drug Betrixaban

October 25, 2016

Portola has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval to market the investigational treatment betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE).

New DMD Drug Candidate Designated Orphan Drug

By October 25, 2016

Solid Biosciences and Solid GT announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for SGT-001 for the treatment of patients with Duchenne muscular dystrophy (DMD).

New Antibiotic for Serious Skin Infections Submitted for FDA Review

By October 24, 2016

Melinta Therapeutics announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval of intravenous (IV) and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).

FDA to Review Opdivo for Urothelial Carcinoma Use

By October 24, 2016

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for Priority Review.

Positive Efficacy Results for Novel Depression Treatment

By October 21, 2016

Positive topline results have been announced for ALKS 5461, a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder.

Positive Results for HCV Combo Drug in Patients with Prior DAA Failure

By October 20, 2016

Gilead has announced positive results from four Phase 3 clinical studies of once-daily, fixed-dose combination of sofosbuvir (SOF), velpatasvir (VEL), and voxilaprevir (VOX; GS-9857), for the treatment of genotype 1-6 chronic hepatitis C infection.

Novel COPD Treatment Shows Benefits in Phase 3 Studies

By October 20, 2016

Theravance Biopharma and Mylan have announced positive results from two replicate Phase 3 studies of revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD).

Letermovir Meets Primary Endpoint in CMV Infection Study

By October 19, 2016

Merck announced that the Phase 3 clinical study of letermovir for the prevention of clinically significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) patients met its primary endpoint.

Positive Results for Elagolix in Two Endometriosis Studies

By October 19, 2016

AbbVie has announced positive results from two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis.

Long-Term Safety Data for Novel Chronic Idiopathic Constipation Drug Announced

By October 17, 2016

At the American College of Gastroenterology (ACG) annual scientific meeting, Synergy presented new long-term safety data of plecanatide for the treatment of chronic idiopathic constipation (CIC).

FDA to Review New Data for Avycaz in Complicated UTI

By October 14, 2016

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam; Allergen), for the addition of new Phase 3 data to the label.

FDA Grants Orphan Drug Status to ALS Treatment

By October 13, 2016

MediciNova announced that the Food and Drug Administration (FDA) has granted orphan drug designation to MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS).

Novel Treatment for Recurrent Vulvovaginal Candidiasis Gets Fast Track Status

By October 13, 2016

Viamet has announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to VT-1161, a novel treatment for recurrant vulvovaginal candidiasis (RVVC).

Priority Review Granted to Lucentis for Vision-Threatening Condition

By October 11, 2016

The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA), and granted Priority Review, for Lucentis (ranibizumab injection; Genentech), to expand its indication for the treatment of myopic choroidal neovascularization (mCNV).

Experimental Drug Shows Promise in Alcohol Use Disorder and Smoking

October 11, 2016

Smokers may also benefit, results of a clinical trial suggest

Neulasta Biosimilar to Be Reviewed by FDA

By October 07, 2016

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 to Neulasta.

Positive Results for Investigational IL-23p19 Inhibitor in Psoriasis Studies

By October 05, 2016

The reSURFACE 1 and 2 trials were randomized, placebo-controlled, multicenter studies designed to demonstrate the efficacy of tildrakizumab in moderate-to-severe plaque psoriasis vs. placebo and comparative drug, and to assess safety and tolerability.

Actemra Designated Breakthrough Therapy for Giant Cell Arteritis

By October 05, 2016

Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition that is more likely to affect women than men.

Guselkumab Goes Head-to-Head with TNF Blocker in Plaque Psoriasis Study

By October 03, 2016

The trial included an active comparator arm evaluating guselkumab vs. adalimumab, which demonstrated the superiority of guselkumab for major study endpoints and through Week 48 of treatment.

Pan-Genotypic HCV Regimen Gets Breakthrough Status

By September 30, 2016

The clinical development program is designed to investigate a pan-genotypic (genotypes 1 to 6) regimen of glecaprevir/pibrentasvir.

New Data on First-in-Class Schizophrenia Drug Announced

By September 29, 2016

Intra-Cellular Therapies have announced inconclusive results from the second Phase 3 trial of ITI-007 (Study '302), a first-in-class investigational medicine for the treatment of schizophrenia.

Neonatal Herpes Simplex Drug Designated Orphan Drug

By September 29, 2016

Neonatal herpes simplex, a life-threatening infection, often produces severe long-term sequelae in the newborn.

Dupilumab Granted Priority Review for Atopic Dermatitis

By September 27, 2016

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD).

NDA Submitted for Spinal Muscular Atrophy Treatment

By September 27, 2016

Biogen and Ionis have completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of nusinersen, an invesigational treatment for spinal muscular atrophy (SMA), for which there is currently no approved treatment.

FDA to Review Fycompa for Monotherapy Use in Partial-Onset Seizures

By September 27, 2016

Eisai announced the submission of a supplemental application for a proposed label change for Fycompa (perampanel) which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy ≥12 years.

Duchenne Muscular Dystrophy Drug Granted Fast Track Status

By September 27, 2016

Summit Therapeutics announced it has received a Fast Track designation from the Food and Drug Administration (FDA) for Ezutromid in the treatment of Duchenne muscular dystrophy (DMD).

Significant PFS Improvement With Combo Tx in Melanoma Study

By September 26, 2016

Array BioPharma and Pierre Fabre announced top-line data from part 1 of the Phase 3 COLUMBUS study evaluating LGX818 (encorafenib) and MEK162 (binimetinib) in patients with BRAF-mutant advanced, unresectable or metastatic melanoma.

Intepirdine Gets Fast Track Status for Lewy Body Dementia

By September 26, 2016

The Food and Drug Administration has granted Fast Track status to Axovant Sciences for their investigational New Drug application for intepirdine for the treatment of dementia with Lewy bodies.

Positive Data for Oral Cannabidiol in Lennox-Gastaut Syndrome Study

By September 26, 2016

GW Pharmaceuticals announced positive data from the second randomized, double-blind, placebo-controlled Phase 3 trial of Epidiolex (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS).

FDA to Review Imbruvica for Rare Lymphoma Indication

By September 26, 2016

Janssen announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib; Janssen and Pharmacyclics) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy.

BLA Submitted for Investigational RA Drug

By September 23, 2016

Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Malaria Vaccine Receives Fast Track Status from FDA

By September 22, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to Sanaria PfSPZ Vaccine, a preventative vaccine for malaria.

FDA to Review Neratinib as Adjuvant Tx for HER2+ Breast Cancer

By September 20, 2016

The FDA has accepted for review the New Drug Application (NDA) for PB272 (oral neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab-based therapy.

Aerosurf Fast Tracked for RDS in Premature Infants

By September 20, 2016

The FDA has granted Fast Track designation to Aerosurf (lucinactant for inhalation; Windtree Therapeutics) for the treatment of respiratory distress syndrome (RDS) in premature infants.

Investigational Estradiol for Dyspareunia Under FDA Review

By September 20, 2016

The FDA has accepted for review the New Drug Application (NDA) for Yuvvexy (17β-estradiol; TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women.

Promising Results for Fixed-Dose Combination Eye Drop for Glaucoma

By September 16, 2016

Aerie Pharmaceuticals announced topline data from the Mercury 1 study, a Phase 3 trial evaluating the fixed-dose combination product, Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, to lower intraocular pressure (IOP) in patients with glaucoma.

Potent Oral Antifungal Granted QIDP Status for Valley Fever

By September 15, 2016

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis, or Valley Fever.

Investigational Shingles Vaccine Evaluated in Patients 70 Years and Older

By September 15, 2016

GlaxoSmithKline (GSK) announced the publication of results from The Phase 3 study, ZOE-70, evaluating the investigational shingles vaccine, Shingrix, in patients aged 70 years and older. Detailed study findings were published in the New England Journal of Medicine (NEJM).

Ocrevus Demonstrates Positive Outcomes in RMS, PPMS Patients

By September 14, 2016

Genentech announced new study analyses from ORCHESTRA, the Phase 3 clinical development program for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

FDA Fast Tracks Potential Treatment for Diabetic Peripheral Neuropathy

By September 13, 2016

The Food and Drug Administration (FDA) has granted NYX-2925 (Aptinyx) Fast Track designation for the potential treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN).

FDA Grants Orphan Drug Status to Coversin for Rare Blood Disorder

By September 13, 2016

The FDA has granted Orphan Drug designation to Coversin (Akari Therapeutics) for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), an ultra-rare, life-threatening and debilitating hematological disorder.

Oral Antibacterial Granted QIDP Status for C. Difficile-Associated Diarrhea

By September 12, 2016

The FDA has granted MGB-BP-3 (MGB Biopharma) Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Significant A1C Reduction Seen for First-in-Class Dual SGLT Inhibitor

By September 09, 2016

Lexicon announced positive findings from the pivotal Tandem 1 study, a Phase 3 trial of sotagliflozin for the treatment of type 1 diabetes.

Nintedanib Designated Orphan Drug for Scleroderma, Associated ILD

By September 09, 2016

The FDA has granted Orphan Drug designation to nintedanib (Boehringer Ingelheim) for the treatment of systemic sclerosis (SSc, or scleroderma), including the associated interstitial lung disease (SSc-ILD).

FDA Grants Orphan Drug Status to OV101 for Rare, Genetic Neurologic Disorder

By September 08, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to OV101 (Ovid Therapeutics) for the treatment of Angelman syndrome, a rare, genetic disorder that causes developmental and neurologic disabilities.

FDA to Review Oral Pharmaceutical Grade L-glutamine for Sickle Cell Disease

By September 08, 2016

Emmaus Life Sciences announced its submission, with request for Priority Review, to the Food and Drug Administration (FDA) a New Drug Application (NDA) for an orally administered pharmaceutical grade L-glutamine (PGLG) for the treatment of sickle cell disease in adults and pediatric patients.

NDA for Novel Glaucoma, Ocular Hypertension Drug Submitted to FDA

By September 08, 2016

Aerie announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for Rhopressa (netarsudil ophthalmic solution) 0.02% to lower intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Fluticasone Furoate/Umeclidinium/Vilanterol Combo Tx Evaluated for COPD

By September 07, 2016

GlaxoSmithKline and Innoviva announced top-line results from the Phase 3 FULFIL study, evaluating the closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25mcg) for the treatment of chronic obstructive pulmonary disease (COPD).

FDA Grants TXA127 Orphan Drug Status for Rare Genetic Skin Disorder

By September 07, 2016

The Food and Drug Administration has granted Orphan Drug designation to TXA127 (Tarix Orphan) for the potential treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder.

Positive Outcomes for Novel Migraine Treatment Lasmiditan

By September 07, 2016

CoLucid Pharmaceuticals announced positive data from the pivotal SAMURAI study, evaluating lasmiditan oral tablets for the acute treatment of migraine in adults, with or without aura.

Sublingual Cyclobenzaprine Evaluated in Fibromyalgia Study

By September 06, 2016

Tonix Pharmaceuticals announced preliminary data from the Phase 3 AFFIRM study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia.

Investigational Postpartum Depression Drug Gets Breakthrough Status

By September 06, 2016

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SAGE-547 (Sage Therapeutics) for the treatment of postpartum depression (PPD).

Benralizumab Demonstrates Efficacy in Severe Asthma Studies

By September 06, 2016

AstraZeneca announced top-line results from two pivotal Phase 3 studies for benralizumab as adjunct to standard-of-care therapy for the treatment of severe asthma with an eosinophilic phenotype.

Aducanumab Granted Fast Track Status for Early Alzheimer's Disease

By September 02, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to the investigational drug aducanumab (Biogen) for the treatment of early Alzheimer's disease (AD).

FDA to Review Valbenazine for Tardive Dyskinesia

By September 01, 2016

Neurocrine Biosciences announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for valbenazine for the treatment of tardive dyskinesia.

Potential Treatment for Melanoma Under FDA Review

By September 01, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for binimetinib (Array BioPharma) for the treatment of NRAS-mutant melanoma.

FDA to Review New Generation Topical Quinolone for Impetigo

By August 31, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ozenoxacin 1% cream (Medimetriks) for the treatment of impetigo.

Fostamatinib Demonstrates Efficacy for Chronic, Persistent ITP

By August 30, 2016

Rigel Pharmaceuticals announced positive data from the Phase 3 study of fostamatinib for the treatment of chronic or persistent immune thrombocytopenia (ITP) in adults.

Potential ALS Treatment Under FDA Review

By August 30, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for edaravone (MCI-186; Mitsubishi Tanabe) for the treatment of amyotrophic lateral sclerosis (ALS).

Skin Substitute Granted Orphan Drug Status for Burn Patients

By August 30, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Regenicin's cultured skin substitute, NovaDerm, for the treatment of burns requiring skin grafting.

Study Highlights Added Benefit of Alirocumab in HeFH Patients Requiring Apheresis

By August 29, 2016

Regeneron and Sanofi announced positive data from ODYSSEY ESCAPE, a Phase 3 study which evaluated Praluent (alirocumab) in patients with heterozygous familial hypercholesterolemia (HeFH) requiring regular apheresis therapy.