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Clinical Research Society

Clinical Research Society

International Society for Clinical Research and Translational Medicine

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us fda

Clinical Research / Pharma News 

Endoceutics’s Intrarosa Gets Approval from US FDA

Dyspareunia, Endoceutics, us fda

The US FDA approved Intrarosa for the treatment of dyspareunia experienced by women who attained menopause. Dyspareunia is moderate to

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Clinical Research / Pharma News Clinical Research and Pharma News 

Eli Lilly’s Lartruvo Gets FDA Accelerated Approval to Treat Soft Tissue Sarcoma

Accelerated Approval, Eli Lilli, Soft tissue sarcoma, us fda

U.S. regulatory authority Food and Drug Administration on 19th October 2016, granted accelerated approval to Eli Lilly’s Lartruvo, a drug

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Clinical Research / Pharma News 

US FDA Discloses Guidance on SaMD for Consultation

International Medical Device Regulators Forum, Software as a medical device, us fda

US regulatory authority Food and Drug Administration (FDA) on 13th October 2016, opened a public a consultation on a harmonized

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Clinical Research / Pharma News 

Exondys 51: First Drug to Treat DMD Gets Approval from US FDA

Duchenne muscular dystrophy, Sarepta Therapeutics, us fda

The US regulatory authority on 18th Sep approved Exondys 51 (eteplirsen), Sarepta Therapeutics’ initial drug to treat individuals with Duchenne

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Clinical Research / Pharma News 

Shire’s Xiidra Gets US FDA Approval

LFA-1, Medication for dry eyes, Shire, us fda

US Food and Drug Administration approved Xiidra, which is lifitegrast ophthalmic solution 5 %,used to treat dry eye disease. Xiidra

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Clinical Research / Pharma News 

First Buprenorphine Implant for Opioid Dependence Gets green Signal from US FDA

implant, Opioid Dependence, us fda

The U.S. Food and Drug Administration on 27th May accepted Probuphine, the first buprenorphine implant for the maintenance therapy of

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Clinical Research / Pharma News 

US FDA Proposes Ban on Powdered Gloves

Ban, Public Citizen, us fda

US Food and Drug Administration (FDA) has chosen to ban most powdered gloves due to the fact that they cause

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Medical News & Articles 

Briviact Received Green Light from US FDA to Treat Partial Onset Seizures

Partial Onset Seizures, UCB, us fda

The US FDA on 18th Feb 2016 accepted Briviact (brivaracetam) as an add-on therapy to other drugs to treat partial

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Clinical Research / Pharma News 

AstraZeneca’s Zurampic Received Green Signal from US FDA

astrazeneca, lesinurad, us fda

The U.S. FDA on 23rd Dec 2015 accepted Zurampic (lesinurad) to treat higher levels of uric acid in the blood

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Medical News & Articles 

Takeda’s Ninlaro Gets Approval from US FDA for Multiple Myeloma

Oral Drug Treatment for Multiple Myeloma, Takeda Pharmaceuticals, us fda

On 20th Nov 2015 the U.S. FDA provided acceptance for  (ixazomib) in combo with two other therapies to treat patients

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