Blog
RSS FeedPosted 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 24 Sep 2017
Allergan receives refusal to file letter from FDA for Vraylar (cariprazine) supplemental new drug application for the treatment of negative symptoms in schizophrenia
22 September 2017 - Allergan today announced that it received a refusal to file letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 24 Sep 2017
Generics industry calls FDA draft guidance on priority reviews 'basically inoperable'
22 September 2017 - A generic drug industry group and several companies have taken issue with recent US FDA draft ...
Posted by Michael Wonder on 23 Sep 2017
Janssen receives complete response letter from U.S. FDA for sirukumab biologics license application
22 September 2017 - Janssen Biotech announced today that it has received a complete response letter from the U.S. FDA for ...
Posted by Michael Wonder on 23 Sep 2017
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent locally advanced or metastatic gastric or gastro-oesophageal junction cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
22 September 2017 - First anti-PD-1 therapy approved in the U.S. for these patients with disease progression on or after two ...