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RSS FeedPosted by Michael Wonder on 26 Jun 2019
FDA approves first treatment for chronic rhinosinusitis with nasal polyps
26 June 2019 - The U.S. FDA today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner ...
Posted by Michael Wonder on 26 Jun 2019
U.S. FDA grants fast track designation to empagliflozin for the treatment of chronic heart failure
26 June 2019 - FDA's Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the ...
Posted by Michael Wonder on 26 Jun 2019
Forward into the past with FDA’s new history exhibit
25 June 2019 - From the “Poison Squad” to AIDS activism, the FDA’s new history exhibit brings the Agency’s past to ...
Posted by Michael Wonder on 26 Jun 2019
Dova Pharmaceuticals announces European Union marketing authorisation for Doptelet (avatrombopag) for the treatment of thrombocytopenia in patients with chronic liver disease
25 June 2019 - Approval Based on Positive Efficacy and Safety Data from Two Phase 3 Clinical Trials. ...
Posted by Michael Wonder on 26 Jun 2019
Pacira BioSciences announces validation of Exparel marketing authorisation application from European Medicines Agency
25 June 2019 - Advances global expansion strategy to minimise post-surgical opioid use worldwide. ...
Posted by Michael Wonder on 26 Jun 2019
Acer Therapeutics receives complete response letter from U.S. FDA for use of Edsivo (celiprolol) in vEDS patients
25 June 2019 - Acer Therapeutics today announced it has received a complete response letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 25 Jun 2019
EMA publishes agenda for 24-27 June CHMP meeting
24 June 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 25 Jun 2019
U.S. FDA accepts GSK’s application for Zejula (niraparib) in late stage ovarian cancer with priority review
24 June 2019 - GlaxoSmithKline plc today announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental new ...
Posted by Michael Wonder on 25 Jun 2019
Krystal Biotech receives regenerative medicine advanced therapy designation from FDA for KB103
24 June 2019 - RMAT designation granted to KB103 based on positive interim data from GEM-1 and GEM-2 study. ...
Posted by Michael Wonder on 25 Jun 2019
Ipsen announces U.S. FDA approval for newly designed pre-filled syringe for Somatuline Depot (lanreotide)
24 June 2019 - New syringe designed to help enhance injection experience. ...
Posted by Michael Wonder on 25 Jun 2019
Nabriva Therapeutics announces EMA validation of marketing authorisation application for lefamulin
24 June 2019 - Nabriva Therapeutics today announced that the EMA has determined that the company’s marketing authorisation application for the ...
Posted by Michael Wonder on 24 Jun 2019
Incorporating patient preferences in non-inferiority trials
24 June 2019 - Non-inferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for ...
Posted by Michael Wonder on 24 Jun 2019
The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies
24 June 2019 - The FDA made a mistake Friday by approving a new drug called Vyleesi for women with ...
Posted by Michael Wonder on 24 Jun 2019
Correvio resubmits Brinavess (vernakalant) new drug application to U.S. FDA for the treatment of patients with recent onset atrial fibrillation
24 June 2019 - Correvio Pharma today announced it has resubmitted a new drug application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 24 Jun 2019
How big pharma suppresses ‘biosimilars’
23 June 2019 - Deals with insurers and pharmacy benefit managers at patient and taxpayer expense. ...