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RSS FeedPosted by Michael Wonder on 30 Sep 2020
The FDA and the importance of trust
30 September 2020 - As SARS-CoV-2 emerged, the global scientific community first studied the virus at the bench, then took what ...
Posted by Michael Wonder on 30 Sep 2020
Janssen submits new drug application to U.S. FDA for Uptravi (selexipag) injection for intravenous use to treat pulmonary arterial hypertension
30 September 2020 - Janssen today announced the submission of a new drug application to the U.S. FDA for Uptravi ...
Posted by Michael Wonder on 30 Sep 2020
Simponi Aria (golimumab) approved by the U.S. FDA for active polyarticular juvenile idiopathic arthritis and extension of its active psoriatic arthritis indication in patients 2 years of age and older
30 September 2020 - Phase 3 GO-VIVA clinical trial adds to the growing body of evidence for Simponi Aria. ...
Posted by Michael Wonder on 30 Sep 2020
Study identifies shortcomings in FDA evaluations for new opioid drug approvals over two decades
29 September 2020 - Systematic assessment of safety-related outcomes has been lacking, researchers find. ...
Posted by Michael Wonder on 30 Sep 2020
Health Canada approves Reblozyl (luspatercept), new class of treatment for adult patients living with beta thalassaemia
29 September 2020 - Reblozyl is the first and only erythroid maturation agent approved for use in Canada. ...
Posted by Michael Wonder on 29 Sep 2020
Infinity receives fast track designation for eganelisib in combination with a checkpoint inhibitor and chemotherapy for first-line treatment of advanced triple negative breast cancer
29 September 2020 - Infinity Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for eganelisib (IPI-549) ...
Posted by Michael Wonder on 29 Sep 2020
Eton Pharmaceuticals announces FDA approval of orphan drug Alkindi Sprinkle (hydrocortisone) as replacement therapy in paediatric patients with adrenocortical insufficiency
29 September 2020 - Alkindi Sprinkle is the first and only FDA approved granular hydrocortisone formulation for adrenocortical insufficiency specifically designed ...
Posted by Michael Wonder on 29 Sep 2020
FDA chief stands by vaccine approval criteria despite Trump pressure
29 September 2020 - The FDA, under commissioner Stephen Hahn, is in the middle of one of the most highly charged ...
Posted by Michael Wonder on 29 Sep 2020
Pfizer CEO on the pressures of creating a COVID-19 vaccine: ‘what is at stake is beyond imagination'
30 September 2020 - Albert Bourla, 58, is chairman and chief executive of Pfizer, a multinational pharmaceutical company. Bourla is a ...
Posted by Michael Wonder on 29 Sep 2020
BridgeBio Pharma and affiliate Origin Biosciences announces FDA acceptance of its new drug application for fosdenopterin for the treatment of MoCD type A
29 September 2020 - Application accepted under priority review designation with breakthrough therapy designation and rare paediatric disease designation previously granted. ...
Posted by Michael Wonder on 29 Sep 2020
Increase transparency at the FDA: we need sunlight to fight the pandemic
29 September 2020 - The FDA has issued a number of contentious decisions during the COVID-19 pandemic related to investigational ...
Posted by Michael Wonder on 29 Sep 2020
Heron Therapeutics receives European Commission authorisation for Zynrelef (HTX-011) for the treatment of post-operative pain
28 September 2020 - Heron Therapeutics today announced that the European Commission has granted a marketing authorisation for Zynrelef (formerly known ...
Posted by Michael Wonder on 29 Sep 2020
Shionogi announces FDA approval of Fetroja (cefiderocol) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia
29 September 2020 - Shionogi today announces that the U.S. FDA has approved a supplemental new drug application for Fetroja ...
Posted by Michael Wonder on 29 Sep 2020
U.S. FDA approves Pfizer's Xeljanz (tofacitinib) for the treatment of active polyarticular course juvenile idiopathic arthritis
28 September 2020 - Pfizer announced today that the U.S. FDA approved Xeljanz (tofacitinib) for the treatment of children and adolescents ...
Posted by Michael Wonder on 28 Sep 2020
Orchard Therapeutics receives EMA PRIME designation for OTL-203 for the treatment of MPS-I
28 September 2020 - Orchard Therapeutics today announced that the EMA has granted Priority Medicines (PRIME) designation to OTL-203, an investigational ...