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RSS FeedPosted by Michael Wonder on 20 Jun 2019
U.S. FDA accepts supplemental biologics license application for Ultomiris (ravulizumab-cwvz) under priority review for the treatment of atypical haemolytic uremic syndrome
20 June 2019 - FDA sets target action date of 19 October 2019. ...
Posted by Michael Wonder on 20 Jun 2019
Sustainable discovery and development of antibiotics — is a non-profit approach the future?
19 June 2019 - Shifting to a nonprofit-driven model for development of antibiotics could encourage discovery and development of truly needed ...
Posted by Michael Wonder on 19 Jun 2019
Melinta Therapeutics announces U.S. FDA acceptance of supplemental new drug application for Baxdela (delafloxacin) for the treatment of community-acquired bacterial pneumonia
19 June 2019 - Application seeks to expand label to include an indication and phase III data for the treatment of ...
Posted by Michael Wonder on 19 Jun 2019
With eyes on Gilead, law makers want details on how HHS reviews possible patent infringement
18 June 2019 - A pair of law makers has asked the Government Accountability Office to review how the U.S. ...
Posted by Michael Wonder on 19 Jun 2019
FDA grants fast track designation for Torque's first deep-primed T cell cancer immunotherapy program, TRQ-1501
18 June 2019 - Torque announced today that the U.S. FDA granted fast track designation for Torque's first Deep-Primed T cell ...
Posted by Michael Wonder on 19 Jun 2019
Abeona Therapeutics receives FDA fast track designation for ABO-202 AAV9 gene therapy in CLN1 disease
18 June 2019 - Abeona Therapeutics today announced that the U.S. Food and FDA has granted fast track designation to its ...
Posted by Michael Wonder on 19 Jun 2019
Health Canada approves Hemlibra for haemophilia A patients without factor VIII inhibitors
18 June 2019 - Hemlibra is the only treatment that can be self-injected subcutaneously once weekly for patients with hemophilia A ...
Posted by Michael Wonder on 18 Jun 2019
FDA approves Merck’s Keytruda (pembrolizumab) as monotherapy for patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy
18 June 2019 - Marks first approval for Keytruda in small cell lung cancer. ...
Posted by Michael Wonder on 18 Jun 2019
Lynparza (olaparib) approved in the EU for use as first-line maintenance therapy in patients with BRCA mutated advanced ovarian cancer
18 June 2019 - Lynparza is the only PARP inhibitor approved in the EU for this indication. ...
Posted by Michael Wonder on 18 Jun 2019
FDA releases new data to help generic drug competitors
18 June 2019 - Generic drug applicants will now have more information from the US FDA when deciding whether to ...
Posted by Michael Wonder on 18 Jun 2019
EMA to reinstate some activities halted by Brexit
17 June 2019 - While noting some progress in its Brexit preparations on transferring medicine marketing authorizations from the UK ...
Posted by Michael Wonder on 18 Jun 2019
Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
18 June 2019 - The U.S. FDA is committed to helping facilitate American patients’ access to lower-cost generic medicines by ...
Posted by Michael Wonder on 17 Jun 2019
Eiger announces breakthrough therapy designation granted by FDA for avexitide for treatment of post-bariatric hypoglycemia
17 June 2019 - Third Eiger pipeline program granted breakthrough therapy designation. ...
Posted by Michael Wonder on 17 Jun 2019
FDA approves new treatment for paediatric patients with type 2 diabetes
17 June 2019 - The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of paediatric patients 10 ...
Posted by Michael Wonder on 15 Jun 2019
Blueprint Medicines submits new drug application to U.S. FDA for avapritinib for the treatment of PDGFRA exon 18 mutant GIST and fourth-line GIST
14 June 2019 - Blueprint Medicines Corporation today announced it has submitted a new drug application to the U.S. FDA for ...