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RSS FeedPosted by Michael Wonder on 26 Nov 2019
EMA adopts EU Ombudsman recommendations to avoid bias concerns over drug approvals
26 November 2019 - Seeking to end another flap about transparency, the European Medicines Agency has agreed to recommendations made ...
Posted by Michael Wonder on 26 Nov 2019
Seattle Genetics announces Health Canada approval of Adcetris (brentuximab vedotin) in combination with chemotherapy in frontline CD30-expressing peripheral T-cell lymphoma
25 November 2019 - Approval of supplemental new drug aubmission for Adcetris in combination with CHP chemotherapy in frontline CD30-expressing peripheral ...
Posted by Michael Wonder on 26 Nov 2019
Phathom Pharmaceuticals provides corporate update
25 November 2019 - Received qualified infection disease pathogen designation from the U.S. FDA for vonoprazan in combination with both amoxicillin ...
Posted by Michael Wonder on 26 Nov 2019
Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
25 November 2019 - European Union marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety ...
Posted by Michael Wonder on 26 Nov 2019
Verastem Oncology announces submission of a marketing authorisation application to the European Medicines Agency for Copiktra (duvelisib)
25 November 2019 - Verastem today announced the submission of a marketing authorisation application to the European Medicines Agency for Copiktra ...
Posted by Michael Wonder on 26 Nov 2019
'Outrageous': banned breast implant maker flouts TGA and safety concerns
25 November 2019 - The Therapeutic Goods Administration is demanding answers from the manufacturer of a banned breast implant after ...
Posted by Michael Wonder on 25 Nov 2019
FDA approves voxelotor for sickle cell disease
25 November 2019 - The Food and Drug Administration has granted accelerated approval to voxelotor (Oxbryta, Global Blood Therapeutics) for ...
Posted by Michael Wonder on 25 Nov 2019
FDA accepts Intercept’s new drug application for OCA for the treatment of liver fibrosis due to NASH and grants priority review
25 November 2019 - NDA supported by positive interim analysis results from the Phase 3 REGENERATE study demonstrating OCA’s improvement of ...
Posted by Michael Wonder on 25 Nov 2019
Zogenix announces FDA acceptance for filing of new drug application and priority review for Fintelpa for the treatment of Dravet syndrome
25 November 2019 - NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met ...
Posted by Michael Wonder on 25 Nov 2019
Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient
25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes. ...
Posted by Michael Wonder on 25 Nov 2019
FDA grants priority review to Roche’s risdiplam for spinal muscular atrophy
25 November 2019 - Filing submission includes 12-month data from pivotal FIREFISH and SUNFISH trials in a broad population of people ...
Posted by Michael Wonder on 25 Nov 2019
FDA approves Aquestive's ALS treatment
22 November 2019 - The U.S. Food and Drug Administration on Friday approved Aquestive Therapeutics’ treatment for neurological disorder amyotrophic ...
Posted by Michael Wonder on 25 Nov 2019
Acalabrutinib receives TGA approval for CLL and SLL cancers
25 November 2019 - The Therapeutic Goods Administration has approved the use of acalabrutinib (Calquence) for the treatment of patients ...
Posted by Michael Wonder on 24 Nov 2019
Lifecycle regulation of artificial intelligence and machine learning–based software devices in medicine
22 November 2019 - Artificial intelligence and machine learning (AI/ML) based technologies aim to improve patient care by uncovering new ...
Posted by Michael Wonder on 24 Nov 2019
Sunovion resubmits new drug application for apomorphine sublingual film
22 November 2019 - Sunovion Pharmaceuticals today announced the resubmission of the new drug application to the U.S. FDA for ...