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Review: Summary and Analysis of the Novel Drug Approvals of FDA in the First Three Quarters of 2017 en-cphi.cn
November 16, 2017
The total number approved in the first three quarters far exceeded that approved in 2016 (FDA approved 22 original novel drugs in total in 2016, including 15 NMEs and 7 BLAs).
FDA Approves FASENRA for Severe Eosinophilic Asthma americanpharmaceuticacreview
November 16, 2017
FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
FDA signals crackdown on controversial painkiller pharmafile
November 16, 2017
Scott Gottlieb, the FDA’s Commissioner, issued an advisory about the medicinal plant-product known as kratom. The plant is known to act as a stimulant in low-doses and has opioid-like effects in higher doses, but whether it is directly harmful is a matter
FDA grants marketing authorization of the first device for use in helping to reduce the symptoms fda
November 16, 2017
FDA permits marketing of the first device for use in helping to reduce the symptoms of opioid withdrawal
FDA Approves Pill with Sensor that Digitally Tracks if Patients Have Ingested Their Medication americanpharmaceuticacreview
November 15, 2017
The U.S. Food and Drug Administration (FDA) approved the first drug in the U.S. with a digital ingestion tracking system.
FDA approves pill that tracks if patients have ingested their medication europeanpharmaceuticalreview
November 15, 2017
The FDA has approved the first drug in the U.S. with a digital ingestion tracking system that records that the medication was taken…
FDA warns about illegal use of injectable silicone for body contouring and associated health risks fda
November 15, 2017
FDA issues safety communication about illegal use of injectable silicone for body contouring and associated health risks
With only 2 warnings in 2017, pharma's ad police hits historic low fiercepharma
November 15, 2017
As the end of the year nears, the pharma industry can usually look back at FDA enforcement letters for insight into the agency's thinking and guidance on marketing communications. But this year, there’s not much to review.
FDA approves pill with sensor biospectrumasia
November 15, 2017
The product is approved for the treatment of schizophrenia
Stryker receives US FDA HDE approval for Neuroform Atlas Stent System biospectrumasia
November 14, 2017
The device is to be utilized in conjunction with neurovascular embolic coils for the treatment of wide neck, intracranial, saccular aneurysms and allows the company to begin U.S. commercialization efforts immediately

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