FDA Grants QDIP Status to Two Inhalation Products

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to two Bayer Healthcare products, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).

Duchenne Muscular Dystrophy Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CAT-1004 (Catabasis) for the treatment of Duchenne Muscular Dystrophy (DMD).

Acute Lymphoblastic Leukemia Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015 for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

Pediatric Ulcerative Colitis Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Avaxia Biologics' investigational therapy, AVX-470 for the treatment of pediatric ulcerative colitis.

Alirocumab Meets Primary Endpoint in Six Hypercholesterolemia Trials

Sanofi and Regeneron announced positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced LDL-C in hypercholesterolemic patients.

Dupilumab Designated Breakthrough Therapy for Atopic Dermatitis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab (Regeneron and Sanofi) for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

FDA Grants Orphan Drug Status to Investigational Acute Myeloid Leukemia Treatment

The FDA has granted Orphan Drug designation to BGB324 (BerGenBio AS) for the treatment of acute myeloid leukemia (AML).

NDA Submitted for Three-Month Paliperidone Palmitate

Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA, for three-month paliperidone palmitate as treatment for schizophrenia in adults.

LCZ696 Cuts Sudden Death, ER Visits in Large HF Study

Novartis announced new data from the Phase 3 PARADIGM-HF study, in patients who received LCZ696 for heart failure with reduced ejection fraction (HFrEF).

Secukinumab Demonstrates Efficacy in Psoriatic Arthritis Trials

Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA).

Lesinurad Demonstrates Efficacy in Phase 3 Gout Trials

AstraZeneca announced top-line results for two pivotal Phase 3 trials investigating lesinurad, when used in combination with xanthine oxidare (XO) inhibitor allopurinol in patients with symptomatic gout not achieving target sUA levels on current allopurinol dose.

Opdivo Achieves Primary Endpoint in Melanoma Trial

Bristol-Myers Squibb Company announced results from the Phase 3 CheckMate-066 study comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.

Combination Therapy Effective in Rheumatoid Arthritis Study

Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase 3b AVERT trial investigating the use of Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve CCP-positive early moderate to severe rheumatoid arthritis (RA) patients.

Development of Brilinta Reversal Agent Initiated by AstraZeneca

AstraZeneca announced that it has initiated a pre-clinical development program to evaluate the ability of investigational antibody, MEDI2452 to rapidly and specifically reverse the antiplatelet effects of Brilinta (ticagrelor) in rare emergencies, such as urgent surgery or major bleeding.

Positive Phase 3 Data of Sebelipase Alfa for LAL Deficiency

Synageva BioPharma announced positive data on sebelipase alfa in a clinical study of patients with lysosomal acid lipase (LAL) deficiency at the American Association for the Study of Liver Diseases' AASLD Liver Meeting.

Brodalumab Demonstrates Efficacy in Plaque Psoriasis Study

Amgen and AstraZeneca announced results from AMAGINE-3, a Phase 3 trial evaluating brodalumab in patients with moderate-to-severe plaque psoriasis.

Sustained Virologic Responses Achieved with Combination Chronic HCV Therapy

Gilead Sciences announced results from three Phase 2 open-label studies investigating the efficacy and safety of an all-oral pan-genotypic regimen containing Sovaldi (sofosbuvir) and GS-5816 for the treatment of chronic hepatitis C virus (HCV) infection.

Interferon-Free Investigational Treatment for Chronic HCV: New Study Results

Enanta Pharmaceuticals announced results from AbbVie's Phase 2b PEARL-I study with ABT-450/ritonavir and ombitasvir, an all-oral, interferon-free investigational treatment combining two direct-acting antivirals with or without ribavirin in patients with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection.

Results Announced for Harvoni in Chronic Hepatitis C Virus Trials

Gilead Sciences announced results from several Phase 2 and Phase 3 studies evaluating the use of Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection.

Investigational Triple Therapy for Chronic HCV Shows Sustained Virologic Response

Merck announced interim data from the C-SWIFT study investigating the triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection.

Sustained Virologic Response with Daclatasvir + Sofosbuvir in Trial

Bristol-Myers Squibb announced late-breaking data from ALLY Trial evaluating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C virus (HCV) patients.

Hepatitis C Virus Combination Therapy Shows Potential in Trials

Bristol-Myers Squibb announced late-breaking results from the UNITY Trial program with all-oral daclatasvir (DCV) TRIO regimen, a fixed-dose combination of daclatasvir with asunaprevir (ASV) and beclabuvir (BCV) in patients with genotype 1 hepatitis C virus (HCV).

Evolocumab BLA Under Review for High Cholesterol

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol.

Tivantinib Improves Progression-Free Survival in Prostate Cancer Trial

ArQule announced positive results from a Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer.

Investigational Night Blindness Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SPK-RPE65 (Spark Therapeutics) for the treatment of nyctalopis, or night blindness, in patients with Leber's congenital amaurosis due to mutations in the RPE65 gene.

NDA Submitted for Single Tablet HIV-1 Infection Regimen

Gilead Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a once-daily single tablet regimen containing elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults.

Lumacaftor + Ivacaftor NDA Submitted for Cystic Fibrosis

Vertex announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the combination product lumacaftor and ivacaftor for people with cystic fibrosis (CF) ages ≥12 who have two copies of the F508del mutation in the cystic fibrosis transmembrance conductance regulator (CFTR) gene.

Isavuconazole Designated Orphan Drug for Invasive Candidiasis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to isavuconazole for the treatment of invasive candidiasis.

Investigational Myelofibrosis Therapy Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to PRM-151 (Promedior) for the treatment of myelofibrosis.

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).

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).

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).

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.

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).

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.

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.

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.

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.

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).

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.

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).

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.

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.

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.

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.

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.

Combination Breast Cancer Therapy Extends Overall Survival

Roche announced results from the Phase 3 CLEOPATRA study evaluating the addition of Perjeta (pertuzumab; Genentech) to Herceptin (trastuzumab; Genentech) and docetaxel chemotherapy in patients with previously untreated HER2-positive metastatic breast cancer.

Cobimetinib + Zelborif Increased PFS in Melanoma Trial

Roche announced positive data from the coBRIM Phase 3 study with cobimetinib plus Zelboraf (vemurafenib) in patients with previously untreated BRAF V600 mutation-positive, advanced melanoma.

Phase 3 Results for Tafinlar in Mutant Metastatic Melanoma

GlaxoSmithKline announced updated results for Tafinlar (dabrafenib) from the Phase 3 BREAK-3 study in patients with BRAF V600E mutant metastatic melanoma.

FDA Grants Aldoxorubicin Orphan Drug Designation

The Food and Drug Administration (FDA) has granted multiple Orphan Drug designations to aldoxorubicin for glioblastoma multiforme, small cell lung cancer, and ovarian cancer.

Vesneo Reduces Intraocular Pressure in Trials

Bausch + Lomb announced positive results from the pivotal Phase 3 studies with Vesneo (latanoprostene bunod) for the reduction of intraocular pressure (IOP) in patients with glaucoma or ocular hypertension.

Efficacy of Oral Testosterone in Hypogonadal Men Demonstrated in Study

Lipocine announced top-line results from its Phase 3 SOAR clinical trial evaluating the efficacy and safety of LPCN 1021, an oral testosterone agent in hypogonadal men with low testosterone.

Nonalcoholic Steatohepatitis Agent Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to aramchol (Galmed) for the treatment of nonalcoholic steatohepatitis (NASH).

Investigational Single Tablet Regimen Noninferior to Stribild for HIV-1 Infection

Gilead announced results from Study 104 and Study 111 evaluating a once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults.

Nosocomial Pneumonia Agent Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track status to MedImmune's investigational monoclonal antibody (mAb), MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Olaptesed Pegol Designated Orphan Drug for Glioblastoma

The FDA has granted Orphan Drug designation to olaptesed pegol (NOX-A12; NOXXON Pharma) for the treatment of glioblastoma in conjunction with radiotherapy.

Rayaldee Efficacious in Secondary Hyperparathyroidism Trial

OPKO Health announced top-line results from the final Phase 3 trial of Rayaldee for the treatment of secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for blinatumomab for the treatment of Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Navidea announced that the Food and Drug Administration (FDA) has granted Lymphoseek (technetium Tc 99m tilmanocept) injection an Orphan Drug Designation for use in sentinel lymph node detection in patients with head and neck cancer.

Xultophy Shows Improved Glycemic Control, Weight Loss in T2DM

Novo Nordisk announced new data from the Phase 3a DUAL clinical trial comparing Xultophy (insulin degludec and liraglutide [IDegLira]) to insulin degludec (Tresiba) and liraglutide (Victoza) alone in insulin-naive and insulin-treated patients.

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

The investigational drug alpelisib (previously known as BYL719) appears to inhibit activation of the pathway that leads to resistance to cetuximab, an anti-epidermal growth factor receptor agent used in the treatment of head and neck cancer.

Cyramza + Paclitaxel Demonstrates Efficacy in Cancer Trial

Eli Lilly and Company announced results from a global Phase 3 study with Cyramza (ramucirumab) in combination with paclitaxel for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

Omarigliptin Significantly Lowers HbA1c Levels in Trial

Merck announced results from the Phase 3 clinical program for omarigliptin, once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes.

Eylea Granted Breakthrough Therapy for Diabetic Retinopathy

The Food and Drug Administration (FDA) has granted Eylea (afilbercept; Regeneron) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

Lynovex Designated Orphan Drug for Cystic Fibrosis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).

Odanacatib Reduces Fracture Risk in Postmenopausal Women

Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.

FDA to Review Tuzistra XR NDA for Cough Cold

The Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for review for Tuzistra XR (CCP-01; Vernalis and Tris Pharma) in the acute treatment of cough cold.

Vyvanse Under Review for Binge Eating Disorder

The Food and Drug Administration (FDA) has accepted for filing Shire's supplemental New Drug Application (sNDA) with priority review for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of adults with binge eating disorder (BED).

Results for Humira in Chronic Skin Disease Trial

AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

FDA Designates Antifungal Agent Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1129 (Viamet Pharmaceuticals), a selective oral antifungal agent, for the treatment of cryptococcal meningitis.

Rolapitant NDA Submitted for Chemotherapy-Induced Nausea and Vomiting

Tesaro has submitted a New Drug Application (NDA) to the FDA for approval of oral rolapitant for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Nintedanib Efficacious in Idiopathic Pulmonary Fibrosis Trials

Boehringer Ingelheim announced results from a pre-specified, pooled subgroup sensitivity analysis from the Phase 3 INPULSIS-1 and INPULSIS-2 trials that evaluated the use of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) based on the severity of lung function impairment at baseline.

Tiotropium Improves Lung Function in Asthma Patients

Boehringer Ingelheim announced results from its Phase 3 UniTinA-asthma trial program evaluating tiotropium in adults, adolescents, and pediatric patients with different severities of asthma.

Isavuconazole Under Review for Invasive Fungal Infections

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole (Astellas) for the treatment of invasive aspergillosis and invasive mucormycosis.

Positive Results for Reslizumab in Asthma Trials

Teva announced positive results from its Phase 3 studies of reslizumab in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies.

Basal Insulin Peglispro Efficacious in Type 1 Diabetes Trials

Basal Insulin Peglispro Efficacious in Type 1 Diabetes Trials

Eli Lilly and Company announced results from its IMAGINE-1 and IMAGINE-3 Phase 3 trials with basal insulin peglispro (BIL) in patients with type 1 diabetes.

FDA Fast Tracks Pulmaquin for Chronic Lung Infections

The Food and Drug Administration (FDA) has granted Fast Track status to Pulmaquin for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients who develop chronic lung infections with Pseudomonas aeruginosa.

Relebactam Designated Qualified Infectious Disease Product Status for Complicated Infections

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product with designated Fast Track status to relebactam (MK-7655; Merck) for intravenous use, in the treatment complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Eravacycline Efficacious in Complicated Urinary Tract Infections Study

Tetraphase announced positive results from the lead-in portion of its IGNITE 2 clinical trial with IV and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).

Eliquis Effective in Reducing All-Cause Hospitalization in Phase 3 Trial

Bristol-Myers Squibb and Pfizer announced results from the pre-specified secondary analysis of the Phase 3 AMPLIFY-EXT trial with Eliquis (apixaban).

Somatuline Depot sNDA Under Review for Gastoenteropancreatic Neuroendocrine Tumors

The Food and Drug Administration (FDA) has accepted and granted Priority Review to Ipsen's sNDA for Somatuline Depot (lanreotide acetate) 120mg injection for the treatment of gastoenteropancreatic neuroendocrine tumors (GEP-NETs).

Myelofibrosis Drug Granted Orphan Drug Status

The Food and Drug Admnistration (FDA) has granted Orphan Drug designation for PRM-151 (Promedior) for the treatment of myelofibrosis.

Nuplazid Designated Breakthrough Therapy for Parkinson's Disease Psychosis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Nuplazid (pimavanserin; Acadia Pharmaceuticals) for the treatment of Parkinson's disease psychosis.

Alirocumab Demonstrates Efficacy in Four Phase 3 Trials

Sanofi and Regeneron announced positive results from four Phase 3 ODYSSEY trials of alirocumab in patients with hypercholesterolemia.

FDA Grants Qualified Infectious Disease Product Status to Two Anti-Infectives

The Food and Drug Administration (FDA) has granted Wockhardt Limited's investigational anti-infectives, WCK 771 and WCK 2349 Qualified Infectious Disease Product (QDIP) status.

Updated Phase 3 Efficacy Results for Ampio

Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.

APD811 Designated Orphan Drug for Pulmonary Arterial Hypertension

The Food and Drug Administration (FDA) has granted Orphan Drug designation to APD811 (Arena Pharmaceuticals) for the treatment of pulmonary arterial hypertension (PAH).

Combination Ovarian Cancer Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to motolimod (VTX-2337; VentiRx) in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.

BLA for Novel Cholesterol Drug Submitted to FDA

BLA for Novel Cholesterol Drug Submitted to FDA

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.

FDA Fast Tracks Clostridium Difficile Vaccine

The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).

First Treatment for Common Anemia Shows Promise

A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.

Chronic Heart Failure Drug Designated Priority Review Status

Chronic Heart Failure Drug Designated Priority Review Status

The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.

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