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RSS FeedPosted by Michael Wonder on 17 Apr 2019
Ultragenyx announces UX007 granted fast track designation and rare pediatric disease designation by U.S. FDA for treatment of long-chain fatty acid oxidation disorders
16 April 2019 - Company on track to submit NDA to FDA in mid 2019. ...
Posted by Michael Wonder on 17 Apr 2019
CRISPR Therapeutics and Vertex announce FDA fast track designation for CTX001 for the treatment of beta thalassemia
16 April 2019 - CRISPR Therapeutics and Vertex Pharmaceuticals Incorporated today announced that the U.S. FDA has granted fast track ...
Posted by Michael Wonder on 16 Apr 2019
Aprea Therapeutics receives FDA fast track designation and orphan drug designation for APR-246 for the treatment of myelodysplastic syndromes
16 April 2019 - Aprea Therapeutics today announced that the U.S. FDA has granted fast track designation to APR-246 for ...
Posted by Michael Wonder on 16 Apr 2019
FDA agrees to rolling review of Mesoblast's biologic licence application for its cell therapy in children with steroid-refractory acute graft versus host disease
16 April 2019 - Mesoblast announced today that the FDA has agreed that Mesoblast can submit on a rolling basis ...
Posted by Michael Wonder on 16 Apr 2019
FDA to launch new website next week
16 April 2019 - In his first “all hands” speech at the US FDA White Oak campus on Tuesday, Acting ...
Posted by Michael Wonder on 16 Apr 2019
Evenity (romosozumab-aqqg) now available in the United States for the treatment of osteoporosis in post-menopausal women at high risk for fracture
15 April 2019 - New therapy to cost one-third less than other bone-building agents over full course of therapy. ...
Posted by Michael Wonder on 15 Apr 2019
FDA approves PureTech’s obesity device Plenity
15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for ...
Posted by Michael Wonder on 15 Apr 2019
Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD
15 April 2019 - Filing is based on Phase III data from the HAWK and HARRIER trials for brolucizumab. ...
Posted by Michael Wonder on 14 Apr 2019
Biopharma CEOs explain problems with biosimilars to Congress
12 April 2019 - Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds ...
Posted by Michael Wonder on 13 Apr 2019
Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications
12 April 2019 - Polyphor's antibiotic murepavadin receives US FDA qualified infectious disease product designation in four new indications. ...
Posted by Michael Wonder on 13 Apr 2019
FDA approves first targeted therapy for metastatic bladder cancer
12 April 2019 - The U.S. FDA today granted accelerated approval to Balversa (erdafitinib), a treatment for adult patients with locally ...
Posted by Michael Wonder on 12 Apr 2019
FDA approves expanded monotherapy label for Merck’s Keytruda (pembrolizumab)
11 April 2019 - Keytruda now approved for first-line treatment of patients with Stage III NSCLC who are not candidates for ...
Posted by Michael Wonder on 11 Apr 2019
On rising insulin prices, law maker tells pharma execs: 'Your days are numbered'
10 April 2019 - Lawmakers tensed with frustration, some clenching their jaws, while grilling a panel of pharmacy and pharmaceutical ...
Posted by Michael Wonder on 11 Apr 2019
Cosmo Pharmaceuticals announces submission of remimazolam NDA TO FDA
9 April 2019 - Cosmo Pharmaceuticals today informed that the Remimazolam NDA has been submitted to FDA. ...
Posted by Michael Wonder on 10 Apr 2019
FDA, Brigham and Women’s to test if RWE is ripe now for replacing clinical drug trials
10 April 2019 - Can real-world evidence substitute for a clinical drug trial that meets the full gold standard on data? ...