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Merck and Pfizer receive FDA approval for kidney cancer therapy

BAVENCIO® (avelumab) plus Axitinib Combination for Patients with Advanced Renal Cell Carcinoma

15-May-2019

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti-PD-L1 therapy as part of a ...

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FDA Accepts File for Cladribine Tablets as Potential Treatment for Relapsing Forms of MS

01-Aug-2018

Merck announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) has been accepted for filing by the U.S. Food and Drug Administration (FDA). “We are delighted the FDA has accepted ...

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Do not try CRISPR at home

Urgent warning from FDA

13-Dec-2017

Gene therapy is the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. Gene therapies offer the potential to treat diseases or conditions for which no or few treatments exist. They ...

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FDA approval brings first gene therapy to the United States

01-Sep-2017

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain ...

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FDA Grants Approval for avelumab

First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma

24-Mar-2017

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC). This indication is approved ...

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FDA Accepts the Biologics License Application for Avelumab for Priority Review

Avelumab could be the first treatment indicated for patients with metastatic Merkel cell carcinoma

30-Nov-2016

Merck and Pfizer Inc. announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab, which was submitted by EMD Serono, the biopharmaceutical business of Merck in the US and Canada. This review relates to avelumab’s ...

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FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

21-Sep-2016

The U.S. Food and Drug Administration approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, ...

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FDA approves first drug to treat hallucinations and delusions associated with Parkinson’s disease

03-May-2016

The U.S. Food and Drug Administration today approved Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. Hallucinations or delusions can occur in as many as 50 percent of ...

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FDA outlines cybersecurity recommendations for medical device manufacturers

19-Jan-2016

The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for ...

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Epigenomics receives FDA notification

11-Jan-2016

Epigenomics announced that the U.S. Food and Drug Administration (FDA) has informed the Company that the already submitted and available data for Epigenomics' blood-based colorectal cancer (CRC) screening test Epi proColon(R) would allow the agency to come to a final determination on its safety ...

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