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Catalent Awarded Grant as Part of a Vaccine Research Consortium

April 23, 2015 10:45 am | by Catalent | News | Comments

Catalent announced that it has received a significant project grant as part of a consortium looking to evaluate, develop and manufacture thermo stable and cold-chain independent nano-pharmaceutical virosome-based vaccine candidates.

FDA Approves First Generic To Treat MS

April 17, 2015 12:16 pm | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (...

Tekmira to Resume Ebola Drug Trials

April 10, 2015 12:00 pm | by Tekmira Pharmaceuticals | News | Comments

The FDA has notified Tekmira that the partial clinical hold on TKM-Ebola has been modified....

EU Approves Roche’s Avastin Therapy

April 9, 2015 12:06 pm | by Roche | News | Comments

The European Commission (EU) approved Avastin in combination with standard chemotherapy for the...

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Fast Track for BioBlast Pharma

April 9, 2015 11:53 am | by BioBlast Pharma | News | Comments

The FDA has granted Fast Track designation to BioBlast's Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy (OPMD).

Prolong Flagship Product Granted Orphan Drug Designation

April 8, 2015 10:57 am | by Prolong Pharmaceuticals | News | Comments

Prolong Pharmaceuticals, LLC, a biopharmaceutical company, announced that the FDA has granted Orphan Drug Designation for its Sickle Cell Disease (SCD) treatment.

New Patent for Low-Sodium Bendamustine

April 7, 2015 12:29 pm | by Eagle Pharmaceuticals | News | Comments

Eagle Pharmaceuticals, Inc. today announced a patent for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. 

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Asia Agencies Purchase U.S. Simulation Software

April 6, 2015 12:01 pm | by Simulations Plus | News | Comments

Simulations Plus announced that several regulatory agencies around the world have added licenses of software for pharmaceutical discovery and development within the past three months.

FDA Approves Sanofi Pasteur’s Quadracel DTaP-IPV Vaccine for Children

March 25, 2015 12:24 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi announced that FDAhas approved use of Quadracel vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

Emergent BioSolutions Receives FDA Approval for Anthrasil

March 25, 2015 11:40 am | News | Comments

Emergent BioSolutions has announced that the FDA has approved Anthrasil™ [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs.

FDA Approves New Treatment for Diabetic Retinopathy in Patients with Diabetic Macular Edema

March 25, 2015 11:31 am | News | Comments

The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

Vertex Gets FDA Approval of KALYDECO® for Children with Cystic Fibrosis

March 18, 2015 3:54 pm | News | Comments

Vertex Pharmaceuticals has announced that the FDA approved KALYDECO® for use in children ages 2 to 5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator ( CFTR) gene.

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Actavis Receives FDA Approval for VIIBRYD

March 17, 2015 8:10 am | News | Comments

Actavis announced that the FDA has approved a lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) to accompany the 40 mg daily therapeutic dose.

FDA Approves Actavis’ SAPHRIS

March 13, 2015 8:15 am | News | Comments

Actavis announced that the FDA has approved its supplemental new drug application (sNDA) for SAPHRIS (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10 - 17).

Powdered Alcohol Gets Fed's Approval

March 12, 2015 8:31 am | by CANDICE CHOI, AP Food Industry Writer | News | Comments

A powdered alcohol intended to be mixed up into drinks has gained approval from a federal regulator. The product, called Palcohol, had received the greenlight from the Alcohol and Tobacco Tax and Trade Bureau briefly last year before the bureau backtracked and said the label approvals had been given in error.

FDA Approves First Biosimilar

March 9, 2015 8:12 am | by MATTHEW PERRONE, AP Business Writer; LINDA A. JOHNSON, AP Business Writer | News | Comments

Government health officials on Friday approved the first lower-cost copy of a biotech drug in the U.S., a long-awaited milestone that could save billions for insurers, doctors and patients.

FDA Approves Opdivo for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer

March 4, 2015 11:04 pm | News | Comments

Bristol-Myers Squibb Company has announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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Pfizer Receives European Approval for New Indication for Prevenar 13

March 3, 2015 8:47 am | News | Comments

Pfizer has announced that the European Commission approved an expanded indication for the use of Prevenar 13 for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.

FDA Approves New Antibiotic Combo from Actavis

February 26, 2015 8:11 am | News | Comments

Federal health officials have approved a new antibiotic combination to treat several hard-to-treat infections. The drug contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria.

FDA Approves Farydak for Treatment of Multiple Myeloma

February 24, 2015 10:14 am | News | Comments

The U.S. Food and Drug Administration has approved Farydak (panobinostat) for the treatment of patients with multiple myeloma. Multiple myeloma is a form of blood cancer that arises from plasma cells, a type of white blood cell, found in bone marrow.

FDA Approves Eisai's LENVIMA for Thyroid Cancer

February 17, 2015 8:27 am | News | Comments

Eisai has announced that the FDA approved the company's receptor tyrosine kinase inhibitor LENVIMA (lenvatinib) for the treatment of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC).

FDA Clears New TB Test

February 13, 2015 8:25 am | News | Comments

The FDA has cleared the Cepheid Xpert MTB/RIF Assay to help physicians determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation.

FDA Approves Genentech’s Lucentis® for Treatment of Diabetic Retinopathy in People With Diabetic Macular Edema

February 9, 2015 7:12 am | News | Comments

Genentech, a member of the Roche Group announced that the FDA approved Lucentis® for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.

Fitch: Breakthrough, Fast Track Therapy Approvals Accelerating

February 3, 2015 3:25 pm | News | Comments

Closer and more frequent communications with the FDA are likely the main factors leading to a shorter approval time for breakthrough drug therapies, according to Fitch Ratings. Breakthrough therapy approvals more than tripled in 2014 versus 2013.

FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder

February 2, 2015 1:34 pm | News | Comments

The FDA has expanded the approved uses of Vyvanse (lisdexamfetamine dimesylate) to treat binge-eating disorder in adults. The drug is the first FDA-approved medication to treat this condition.          

Zogenix Gets Approval for New Version of Zohydro

February 2, 2015 11:29 am | News | Comments

Zogenix has received U.S. approval for a new formulation of its much-debated painkiller Zohydro that is intended to be harder to abuse, though the company is still working on studies needed to promote that claim.       

FDA Approves Glyxambi Tablets for Adults with Type 2 Diabetes

February 2, 2015 10:59 am | News | Comments

The FDA has approved Glyxambi (empagliflozin/linagliptin) tablets, from Boehringer Ingelheim Pharmaceuticals and Eli Lilly as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D) when both empagliflozin and linagliptin are appropriate treatments.

FDA Approves BMS’s Evotaz™ for the Treatment of HIV-1 Infection in Adults

January 30, 2015 8:42 am | News | Comments

Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.   

FDA Approves IMBRUVICA for Treatment of Waldenstrom's Macroglobulinemia

January 29, 2015 12:54 pm | News | Comments

Pharmacyclics has announced that the FDA has granted single-agent IMBRUVICA (ibrutinib) regular (full) approval in all lines of therapy as the first and only treatment for patients with Waldenstrom's macroglobulinemia (WM), a rare, indolent type of B-cell lymphoma.

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