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RSS FeedPosted by Michael Wonder on 09 Oct 2017
Tagrisso granted breakthrough therapy designation by US FDA for the first-line treatment of patients with EGFR mutation-positive non-small cell lung cancer
9 October 2017 - Designation based on positive Phase III FLAURA trial results. ...
Posted by Michael Wonder on 08 Oct 2017
Adynxx completes enrolment in ADYX-004, a Phase 2 study of brivoligide, lead compound for the treatment of post-surgical pain
4 October 2017 - ADYX-004 study to evaluate safety and efficacy of a single pre-operative dose of brivoligide for the ...
Posted by Michael Wonder on 08 Oct 2017
Athersys to present at 2017 Cell & Gene Meeting on the Mesa and announces regenerative medicine advanced therapy designation from FDA
5 October 2017 - Athersys announced today that Robert W. Mays, Ph.D., Vice President, Regenerative Medicine and Head of Neuroscience ...
Posted by Michael Wonder on 07 Oct 2017
Neurocrine announces FDA approval of 80 mg Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia
5 October 2017 - First and only tardive dyskinesia therapy taken as one capsule, once per day; new 80 mg capsule ...
Posted by Michael Wonder on 07 Oct 2017
Flexion Therapeutics announces FDA approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis knee pain
6 October 2017 - Product label also includes positive data from type 2 diabetes study. ...
Posted by Michael Wonder on 07 Oct 2017
FDA approves implantable device to treat moderate to severe central sleep apnea
6 October 2017 - The U.S. FDA today approved a new treatment option for patients who have been diagnosed with ...
Posted by Michael Wonder on 07 Oct 2017
FDA awards six grants for natural history studies in rare diseases
6 October 2017 - The U.S. FDA today announced it has awarded six new research grants for natural history studies ...
Posted by Michael Wonder on 07 Oct 2017
FDA awards 15 grants for clinical trials to stimulate product development for rare diseases
6 October 2017 - The U.S. FDA today announced that it has awarded 15 new clinical trial research grants totalling ...
Posted by Michael Wonder on 04 Oct 2017
Takeda announces FDA approval of Alunbrig (brigatinib) 180 mg tablets
3 October 2017 - New dosing option will reduce pill burden for patients living with ALK positive non-small-cell lung cancer. ...
Posted by Michael Wonder on 04 Oct 2017
Expanded access: FDA describes efforts to ease application process
3 October 2017 - FDA has a long history of supporting patient access to investigational new treatments. ...
Posted by Michael Wonder on 04 Oct 2017
Mylan announces U.S. FDA approval of first generic for Copaxone 40 mg/mL 3-times-a-week and may be eligible for 180-day exclusivity
3 October 2017 - Mylan also receives U.S. FDA approval of generic for Copaxone 20 mg/mL once daily. ...
Posted by Michael Wonder on 04 Oct 2017
FDA approves Botox Cosmetic (OnabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults
3 October 2017 - Botox Cosmetic is the only treatment of its kind approved by the FDA for forehead lines, ...
Posted by Michael Wonder on 04 Oct 2017
FDA accepts supplemental new drug application filing for Avycaz (ceftazidime and avibactam)
2 October 2017 - Application seeks to expand label to include an indication and phase 3 data for the treatment of ...
Posted by Michael Wonder on 03 Oct 2017
Sucampo Pharmaceuticals announces FDA acceptance of sNDA for Amitiza in children with paediatric functional constipation, with priority review designation
28 September 2017 - Sucampo Pharmaceuticals today announced that the U.S. FDA has accepted for filing its recently submitted supplemental ...
Posted by Michael Wonder on 03 Oct 2017
Seattle Genetics receives FDA breakthrough therapy designation for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin lymphoma
2 October 2017 - Designation based on positive Phase 3 ECHELON-1 trial evaluating Adcetris in front-line advanced Hodgkin lymphoma; data will ...