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RSS FeedPosted by Michael Wonder on 28 Sep 2017
Lannett receives FDA approval for oxycodone and acetaminophen tablets, 5 mg/325 mg and 10 mg/325 mg
27 September 2017 - Lannett today announced that it received approval from the U.S. FDA of its abbreviated new drug ...
Posted by Michael Wonder on 28 Sep 2017
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration
27 September 2017 - The U.S. FDA today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose ...
Posted by Michael Wonder on 27 Sep 2017
Application for additional indication of Lenvima for hepatocellular carcinoma accepted for review by U.S. FDA
27 September 2017 - Eisai has announced that the application submitted for an additional indication of its in-house discovered and ...
Posted by Michael Wonder on 27 Sep 2017
Making advances against Sickle cell disease
26 September 2017 - The medical definition of sickle cell disease – a group of inherited red blood cell disorders caused ...
Posted by Michael Wonder on 27 Sep 2017
FDA selects participants for new digital health software pre-certification pilot program
26 September 2017 - Today, the U.S. FDA announced the names of the companies selected to participate in a first-of-its ...
Posted by Michael Wonder on 26 Sep 2017
FDA approves Grifols Prolastin-C liquid [alpha-1 proteinase inhibitor, liquid] for the treatment of alpha-1 anti-trypsin deficiency
22 September 2017 - Prolastin-C Liquid is the first liquid formulation of an alpha-1 anti-trypsin deficiency replacement therapy manufactured in the ...
Posted by Michael Wonder on 26 Sep 2017
How patient preferences contribute to regulatory decisions for medical devices
25 September 2017 - Since we launched our Patient Preference Initiative as part of our medical device regulatory decision-making process ...
Posted by Michael Wonder on 26 Sep 2017
FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online
25 September 2017 - Illegally marketed opioids are among the products targeted, along with the websites that sell them, during international ...
Posted by Michael Wonder on 26 Sep 2017
Aradigm announces FDA acceptance of NDA for Linhaliq with priority review status
25 September 2017 - Aradigm today announced that the U.S. FDA has accepted for filing with priority review its new ...
Posted by Michael Wonder on 25 Sep 2017
Camurus announces that FDA grants priority review of NDA for weekly and monthly CAM2038 buprenorphine depots for treatment of opioid use disorder
18 September 2017 - Camurus announces that the U.S. FDA has accepted the new drug application for weekly and monthly CAM2038 ...
Posted by Michael Wonder on 25 Sep 2017
U.S. FDA grants fast track designation for Amicus Therapeutics' migalastat for treatment of Fabry disease
19 September 2017 - New drug application submission on track for 4Q17. ...
Posted by Michael Wonder on 25 Sep 2017
Intellipharmaceutics receives complete response letter from the FDA for Rexista NDA
25 September 2017 - FDA response provides path toward commercialisation of Rexista. ...
Posted by Michael Wonder on 25 Sep 2017
BioCryst's Rapivab (peramivir injection) receives FDA approval for a paediatric indication
21 September 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has approved a supplemental new drug application for ...
Posted by Michael Wonder on 25 Sep 2017
Many drug companies fail to conduct timely safety checks on medicines after FDA approval
22 September 2017 - In the rush to approve new medicines, the U.S. FDA often requires drug companies to study ...
Posted by Michael Wonder on 25 Sep 2017
Kiadis Pharma receives FDA Regenerative Medicine Advanced Therapy designation for ATIR101
20 September 2017 - Kiadis Pharma today announces that the US FDA has granted ATIR101, Kiadis Pharma’s lead investigational product for ...