Bayer’s Skyla Receives FDA Approval

The Food and Drug Administration (FDA) have given approval to the new long-term contraceptive, Skyla, Bayer announced yesterday. Regulators in the USA have given the green light to Skyla, a low-dose levonorgestrel-releasing intrauterine system (IUS).  The small, flexible plastic T-shaped device, which contains 13.5 mg of the progestin hormone, is positioned in the uterus for

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FDA Accepts Orexo’s Zubsolv for Review

Sweden’s Orexo has revealed that the US Food and Drug Administration (FDA) have accepted the New Drug Application (NDA) for their opioid dependence drug, Zubsolv, for review. Zubsolv is a sublingual formulation of Reckitt Benckiser’s Suboxone which governs a market that is predicted to reach sales of $1.5 billion in 2012 and continues to exhibit

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Pfizer’s Xeljanz Approved by US FDA

Pfizer are celebrating today after US regulators approved their rheumatoid arthritis drug, Xeljanz, yesterday.  The treatment is the first Janus kinase (JAK) inhibitor to be approved for rheumatoid arthritis. The US Food and Drug Administration (FDA) have given the green light to Xeljanz (tofacitinib) 5mg twice-daily for the medication of adults with moderately to severely

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Teva’s Version of Neupogen Approved by FDA

The US FDA (Food and Drug Administration) have approved Teva Pharmaceutical Industries’ form of Amgen’s severe neutropenia therapy, Neupogen. The FDA have approved tbo-filgrastim, which Teva noted is the first new granulocyte colony-stimulating factor (G-CSF) to be backed by the US agency in over 10 years.  The drug is a copy of Neupogen (filgrastim), which

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Horizon’s Rayos and Amarin’s Vascepa Approved by FDA

The US Food and Drug Administration (FDA) have announced that they have approved Amarin Corp’s heart pill, Vascepa, and Horizon Pharma’s anti-inflammatory, Rayos. The FDA approved Vascepa (icosapent ethyl), formerly known as AMR101, as an addition to diet to reduce triglyceride (levels in adult patients with severe hypertriglyceridemia).  Triglycerides is a blood fat that contributes

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Novartis’ Afinitor Approved for Breast Cancer by FDA

Novartis announced on Friday that they have received approval from US regulators for Afinitor as a treatment for advanced breast cancer. The US Food and Drug Administration (FDA) have given the thumbs up to Afinitor (everolimus) for use with Pfizer’s Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.  The

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Anthrax Antibody Resubmitted to US FDA by HGS

A week prior to the closing date Human Genome Sciences (HGS) have fixed for prospective buyers to submit bids, HGS have announced that US regulators are to review raxibacumab again for the treatment’s previously-rejected anthrax medication. The US Food and Drug Administration (FDA) have confirmed the receipt of the resubmission of the Biologics License Application

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US FDA Approves Erbitux for KRAS Wild-Type Cancer

A new indication for Bristol-Myers Squibb (BMS) and Eli Lilly’s Erbitux, which is sold outside the USA by Merck KGaA, has been approved by US regulators. Meanwhile, the US Food and Drug Administration (FDA) have also cleared the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit which was developed by the Netherlands-based firm,

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