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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...

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...

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...

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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.

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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.

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.

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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.          

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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.

FDA Approves Teva's Generic Nexium® Delayed-Release Capsules

January 27, 2015 7:06 am | News | Comments

Teva Pharmaceutical has announced the Food and Drug Administration (FDA) approval of the first generic equivalent to Nexium (esomeprazole magnesium) Delayed-Release Capsules in the United States.         

CHMP Issues Positive Opinion for Merck's Investigational Antibiotic SIVEXTRO®

January 26, 2015 11:00 am | News | Comments

Merck announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® for the treatment of acute bacterial skin and skin structure infections in adults.

FDA Approves Symplmed's Prestalia® for Treatment of Hypertension

January 26, 2015 10:44 am | News | Comments

Symplmed Pharmaceuticals has announced that the FDA has approved Prestalia® (perindopril arginine and amlodipine) tablets, licensed from Servier (Suresnes, France), for the treatment of hypertension.         

Impax Receives FDA Approval for a Generic Version of Lamictal

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

Impax Laboratories announced today that the  FDA has approved generic Lamictal (lamotrigine) Orally Disintegrating Tablets, 25mg, 50mg, 100mg and 200mg in blister packaging. Impax will promptly initiate commercialization of this product through Global Pharmaceuticals, Impax's generic division.

FDA Approves Baxter's PHOXILLUM Solution for Electrolyte Management During Continuous Renal Replacement Therapy

January 21, 2015 8:15 am | News | Comments

Baxter International has announced the FDA has approved PHOXILLUM Renal Replacement Solutions as replacement solutions in continuous renal replacement therapy to correct electrolyte and acid-base imbalances, and in case of drug poisoning when CRRT is used to remove dialyzable substances.

Fresenius Kabi Receives FDA Approval for Neostigmine Methylsulfate Injection

January 19, 2015 9:33 am | News | Comments

This is the first Fresenius Kabi drug approved by the FDA since the agency upgraded the status of the company’s pharmaceutical manufacturing facility in Grand Island, N.Y., earlier this month.           

FDA Approves Appetite-Zapping Implant for Obese Patients

January 14, 2015 4:24 pm | News | Comments

The Maestro Rechargeable System uses electrodes implanted in the abdomen to stimulate the vagus nerve, which signals to the brain that the stomach is empty or full. Patients and doctors can adjust the device settings using external controllers. 

FDA Approves Cytori's Scleroderma Trial

January 12, 2015 8:15 am | News | Comments

Cytori Therapeutics announced today that the Center for Biologics Evaluation and Research, a division of the FDA, has given final approval to its application for an Investigational Device Exemption to begin a pivotal trial to evaluate Cytori Cell Therapy™ as a potential treatment for impaired hand function in scleroderma.

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