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222 Current news of FDA

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 ...

dementia dopamine drugs +2

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19-Jan-2016 - The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the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 The draft guidance details the agency’s recommendations for ...

control systems maintenance medical devices +2

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 ...

blood tests cancer diagnostics colon cancer +1
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Merck and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab

20-Nov-2015 - Merck and Pfizer announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after ...

avelumab cancer Merck +1

Higher nicotine, carcinogen levels among smokeless tobacco users compared with cig users

19-Nov-2015 - U.S. adults who used only smokeless tobacco products had higher levels of biomarkers of exposure to nicotine and a cancer-causing toxicant -- the tobacco-specific nitrosamine NNK -- compared with those who used only cigarettes. Even though smokeless tobacco is used less than cigarettes, it ...

biomarkers cancer nicotine +2

FDA approves new therapy for certain types of advanced soft tissue sarcoma

27-Oct-2015 - The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for ...

anthracycline chemotherapy liposarcoma +1

Merck and Pfizer Receives FDA Fast Track Designation

09-Oct-2015 - Merck and Pfizer announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer. This ...

carcinoma Fast Track status Merck +3

Rett syndrome: Newron Receives FDA Orphan Drug Designation for Sarizotan

15-Jul-2015 - Newron Pharmaceuticals S.p.A. announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Newron’s New Chemical Entity (NCE) sarizotan for treatment of Rett syndrome. Newron also recently announced that it received a positive opinion from the Committee for ...

Orphan Drug Designation Rett Syndrome

FDA Awards Isarna Orphan Drug Designation for ISTH0036 to Improve Glaucoma Treatment Outcome

12-Jun-2015 - Isarna Therapeutics announced that the Food and Drug Administration (FDA) has granted orphan drug designation for ISTH0036, a locked nucleic acid-modified antisense oligonucleotide, for the prevention of scarring post glaucoma filtration surgery. The FDA decision follows recently announced EMA ...

glaucoma oligonucleotides ophthalmology +2

FDA Grants Orphan Status for ATX-F8-117 for the treatment of Haemophilia A patients in the US

11-Jun-2015 - Apitope announced that pre-clinical product candidate ATX-F8-117 has been granted Orphan Drug Status by the US Food and Drug Administration (FDA) for the prevention or treatment of inhibitors in haemophilia A patients with inhibitors or at the risk of producing inhibitors. Commenting on the ...

hemophilia A Orphan Drug Designation