Blog
RSS FeedPosted by Michael Wonder on 30 Jul 2019
NeuroVive’s NeuroSTAT project receives FDA fast track designation
27 July 2019 - NeuroVive Pharmaceutical today announced that the company’s candidate drug NeuroSTAT, in development for treatment of moderate ...
Posted by Michael Wonder on 30 Jul 2019
FDA requires box warnings for Pfizer drug Xeljanz
26 July 2019 - Patients taking 10 mg dose twice a day could experience a higher risk of blood clots or ...
Posted by Michael Wonder on 30 Jul 2019
Moving from substantial equivalence to substantial improvement for 510(k) ddevevices
29 July 2019 - Medical devices have been receiving more public attention and scrutiny in recent years because of safety problems. ...
Posted by Michael Wonder on 29 Jul 2019
FDA updates draft guidance on rare paediatric disease priority review voucher program
29 July 2019 - The U.S. FDA today issued a revised draft guidance, Rare Paediatric Disease Priority Review Vouchers – ...
Posted by Michael Wonder on 29 Jul 2019
FDA’s Sharpless outlines FDA's 4 top priorities: tech, hiring, modernisation and increased safety
24 July 2019 - Acting U.S. FDA Commissioner Ned Sharpless emailed agency staff yesterday outlining the FDA’s four main priorities. ...
Posted by Michael Wonder on 29 Jul 2019
Harms from uninformative clinical trials
25 July 2019 - Individuals who enroll in clinical trials do so with the belief that their participation will help ...
Posted by Michael Wonder on 26 Jul 2019
Surrogate endpoints in randomised controlled trials: a reality check
27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI ...
Posted by Michael Wonder on 26 Jul 2019
Breakthrough drugs raise worries over higher costs
25 July 2019 - Potential breakthroughs in medical treatment for serious diseases are turning what was once “the stuff of ...
Posted by Michael Wonder on 26 Jul 2019
Matinas BioPharma receives qualified infectious disease product and fast track designations from U.S. FDA for MAT2203 for the treatment of cryptococcal meningitis
25 July 2019 - Fourth QIDP and fast track designations granted by FDA for MAT2203. ...
Posted by Michael Wonder on 26 Jul 2019
FDA approves Feraccru with a broad label of treating iron deficiency in adults
26 July 2019 - Feraccru to be marketed as Accrufer in the USA. ...
Posted by Michael Wonder on 25 Jul 2019
Aptar’s nasal unidose device approved by US FDA for first needle-free rescue treatment for severe hypoglycaemia
25 July 2019 - AptarGroup today announced that its Unidose Powder System was recently approved by the U.S. FDA for an ...
Posted by Michael Wonder on 25 Jul 2019
Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat for the treatment of epithelioid sarcoma
25 July 2019 - Company aligns with FDA on planned confirmatory study design for tazemetostat in epithelioid sarcoma. ...
Posted by Michael Wonder on 25 Jul 2019
U.S. FDA accepts Correvio's resubmitted new drug application for Brinavess (vernakalant)
25 July 2019 - NDA seeks pproval for Brinavess for the treatment of recent onset atrial fibrillation; PDUFA date set for ...
Posted by Michael Wonder on 24 Jul 2019
FDA approves Pfizer's biosimilar Ruxience (rituximab-pvvr), for certain cancers and auto-immune conditions
23 July 2019 - Pfizer today announced the United States FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), ...
Posted by Michael Wonder on 24 Jul 2019
Aeglea BioTherapeutics receives FDA breakthrough therapy designation for pegzilarginase for treatment of arginase 1 deficiency
24 July 2019 - Designation follows recently reported ARG1-D Phase 1/2 data demonstrating clinical response in patients rreated with pegzilarginase. ...