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Brexit's trick or treat on patient safety cphi-online
May 05, 2019
Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation.
FDA Orders Important Safety Labeling Changes for Addyi Regarding Alcohol Consumption drugs
April 17, 2019
FDA Orders Important Safety Labeling Changes for Addyi Regarding Alcohol Consumption.
Device-safety experts to FDA: Make data public fiercepharma
March 28, 2019
Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices.
Breast implants reveal problems in tracking device safety foxbusiness
November 27, 2018
To all the world, it looked like breast implants were safe. From 2008 to 2015, the U.S. Food and Drug Administration publicly reported 200 or .....
FDA launches global operation to crack down on websites selling illegal, potentially dangerous drugs worldpharmanews
October 24, 2018
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, acted this week to target 465 websites that illegally sell potentially dangerous, unapproved versions of opioid, oncology and antiviral presc
Up to 10-years of follow-up data reaffirm safety profile of Mavenclad (cladribine tablets) worldpharmanews
October 12, 2018
Merck, the vibrant science and technology company, today announced the presentation of new data for MAVENCLAD® (cladribine tablets) at the 34th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS) in Berlin, German
Europe recalling some valsartan meds on safety fears pharmatimes
July 09, 2018
The European Medicines Agency is reviewing medicines containing valsartan supplied by a facility in China after a potentially cancer-causing impurity was detected.
Jardiance® (empagliflozin) analysis reinforces established safety profile lilly
June 15, 2017
An analysis of pooled safety data from 19 studies, including the EMPA-REG OUTCOME® trial, involving more than 12,500 adults with type 2 diabetes demonstrated treatment with Jardiance® (empagliflozin) tablets...
Patient death sparks safety worries in Ionis trial pharmafile
May 17, 2017
Ionis Pharmaceuticals announced the results from a Phase 3 trial of its drug to treat patients with familial amyloid polyneuropathy and the results were extremely positive, except for the side-effects.
Longeveron Announces Phase 1 Safety, Efficacy Results for Allogeneic Stem Cell Treatment americanpharmaceuticalreview
May 17, 2017
Longeveron announced publication of Phase 1 safety, tolerability and efficacy data of its proprietary allogeneic mesenchymal stem cell (MSC) product in patients with Aging Frailty. The results were published on April 21st online in the Journals of Geronto

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