Regulatory Affairs News Channel

FDA updates warnings for fluoroquinolone antibiotics

FDAThe U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.

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FDA approves new medication for dry eye disease

FDAThe U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra is the first medication in a new class of drugs, called lymphocyte function-associated antigen 1 (LFA-1) antagonist, approved by the FDA for dry eye disease.

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FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests

FDAIn support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person's genomic makeup.

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FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX

FDAThe U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers.

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FDA approves first buprenorphine implant for treatment of opioid dependence

FDAThe U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.

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FDA approves new treatment for inhalation anthrax

FDAOn Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

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Launch of PRIME - Paving the way for promising medicines for patients

EMAThe European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines that target an unmet medical need. The scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients with no treatment options. These medicines are considered priority medicines within the European Union (EU).

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A new method cuts the cost of drug-…

EPFL (École polytechnique fédérale de Lausanne) scientists design a new method to cheaply produce some of the most important chemical compounds in the pharmaceutical indu...

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Six leading scientists to receive p…

Today Novartis announced that six scientists will receive the 2016 Novartis Prizes for Immunology at the upcoming 16th International Congress of Immunology (ICI) in Melbo...

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Pfizer announces publication of new…

Pfizer Inc. (NYSE:PFE) announced the publication of a new post-hoc analysis of data from three studies of VYNDAQEL in patients with mild transthyretin familial amyloid po...

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Why is breast cancer common but hea…

Malignant cancers strike certain organs, such as the colon or breast, more often than others. In an Opinion publishing August 9 in Trends in Cancer, researchers propose t...

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Legions of nanorobots target cancer…

Researchers from Polytechnique Montréal, Université de Montréal and McGill University have just achieved a spectacular breakthrough in cancer research. They have develope...

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Amgen and Advaxis enter global canc…

Amgen (NASDAQ:AMGN) and Advaxis, Inc. (NASDAQ:ADXS) announced a global agreement for the development and commercialization of Advaxis' ADXS-NEO, a novel, preclinical inve...

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Researchers develop safer opioid pa…

An international team of researchers - led by scientists at UC San Francisco, Stanford University, the University of North Carolina (UNC), and the Friedrich-Alexander Uni...

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Natural compound from a deep-water …

Scientists at Florida Atlantic University's Harbor Branch Oceanographic Institute found that a deep-water marine sponge collected off of Fort Lauderdale's coast contains ...

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Esketamine receives Breakthrough Th…

Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that the U.S. Food and Drug Administration (FDA) has gran...

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Intestinal flora effects drug respo…

Intestinal flora has multiple influences on human health, but researchers have revealed that it is also likely to have an effect on the body's response to drugs. Recent r...

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Tumor shrinkage is not the only measure of a successful anti-cancer therapy. A University of Colorado Cancer Center article published in the journal Frontiers in Oncology...

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