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Canadians wait 462 days for access to new drugs

May 22, 2015 8:59 am | by Jason Lomberg, Editor, @PharmProEditor | Blogs | Comments

During the hullabaloo surrounding passage of President Obama’s signature piece of legislation, the Patient Protection and Affordable Care Act (aka, Obamacare), proponents extolled the virtues of Canada’s free healthcare system. Critics slammed that same system for its alleged wait times....

J&J Pharmaceuticals Announces 10 filings for Blockbuster Drugs by 2019

May 20, 2015 10:43 am | News | Comments

At a meeting today with analysts, Johnson & Johnson's Janssen Pharmaceuticals announced...

Investigational Hep C Drugs Receive Breakthrough Therapy Designation

May 20, 2015 10:20 am | by Business Wire | News | Comments

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA)...

FDA approves new medication to treat schizophrenia

May 20, 2015 10:12 am | by Janssen Pharmaceuticals | News | Comments

There’s a new treatment option for schizophrenia – INVEGA TRINZA (three-month paliperidone...

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Eagle Pharmaceuticals Receives Patent for Rapid Infusion Product

May 19, 2015 8:59 am | by Business Wire | Teva Pharmaceuticals Usa | News | Comments

Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. Patent No. 9,034,908, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes.

Puma Biotech Stumbles With Breast Cancer Drug

May 15, 2015 11:53 am | by The Associated Press | News | Comments

Treatment results with the breast cancer drug Herceptin, as well as chemotherapy, did improve, but the drug's backers had been hoping to see better results.

ANI Acquires Rights to Testosterone Gel 1%

May 13, 2015 11:31 am | by ANI Pharmaceuticals | News | Comments

ANI Pharmaceuticals has acquired the approved new drug application ("NDA") for a testosterone gel 1% product previously licensed to Teva Pharmaceuticals.

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FDA Panel Backs Vertex Combination Pill for Cystic Fibrosis

May 13, 2015 11:23 am | by Matthew Perrone, AP Health Writer | News | Comments

Federal health advisers recommended approval for an experimental combination drug to treat cystic fibrosis, despite unresolved questions about the benefit of one of the pill's two ingredients.

FDA Fast Tracks Sucampo's Cobiprostone

May 11, 2015 10:28 am | by Sucampo Pharmaceuticals | News | Comments

The FDA has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator for the prevention of oral mucositis.

FDA Questions Benefit of Cystic Fibrosis Drug From Vertex

May 8, 2015 11:39 am | by Matthew Perrone, AP Health Writer | News | Comments

The Food and Drug Administration said in an online review that the benefit was small and it is unclear if the addition of a second drug ingredient adds to the pill's effectiveness.

Mylan Launches Generic Seasonale Tablets

May 7, 2015 11:50 am | by Mylan N.V. | News | Comments

Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets.

Portola Pharmaceuticals Q1 Results

May 7, 2015 11:35 am | by Portola Pharmaceuticals | News | Comments

Portola Pharmaceuticals today provided a corporate update and reported its financial results for the first quarter.

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FDA Approves Spray-On Surgical Sealant

May 1, 2015 10:46 am | by FDA | News | Comments

The FDA today approved Raplixa, the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.

Vernalis, Tris Pharma Receive FDA Approval for Tuzistra XR

May 1, 2015 10:36 am | by Vernalis | News | Comments

Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine in treating coughs and upper respiratory allergies.

FDA Approves First Generic Abilify

April 29, 2015 11:22 am | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole).

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 (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

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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. Tekmira plans to resume the TKM-Ebola Phase I clinical trial in the coming weeks.

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 treatment of adult patients with carcinoma of the cervix.

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. 

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.

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).

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