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RSS FeedPosted by Michael Wonder on 12 Dec 2019
Avenue Therapeutics announces submission of new drug application for IV tramadol
11 December 2019 - Avenue Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 12 Dec 2019
Kite submits biologics license application to U.S. FDA for Company’s second CAR T cell therapy
11 December 2019 - Investigational KTE-X19 to be first chimeric antigen receptor T cell therapy for mantle cell lymphoma if approved. ...
Posted by Michael Wonder on 11 Dec 2019
Biosimilar stakeholders praise removal of biologic exclusivity provisions from USMCA
11 December 2019 - An agreement on the United States–Mexico–Canada Agreement, a trade deal that updates the North American Free ...
Posted by Michael Wonder on 11 Dec 2019
FDA accepts supplemental biologics license application for Xolair (omalizumab) for the treatment of nasal polyps
10 December 2019 - The submission is based on positive results from the Phase III POLYP 1 and POLYP 2 studies ...
Posted by Michael Wonder on 11 Dec 2019
Strategic need for large prospective studies in different populations
9 December 2019 - Retrospective studies, in which well-characterized individuals with a particular disease are compared with control individuals without the ...
Posted by Michael Wonder on 10 Dec 2019
Equillium granted U.S. FDA fast track designation for itolizumab for the treatment of lupus nephritis
9 December 2019 - Equillium today announced that the U.S. FDA has granted fast track designation for itolizumab for the ...
Posted by Michael Wonder on 10 Dec 2019
FDA approves etectRx ‘digital pill’ as rivals struggle
10 December 2019 - The FDA has approved an ingestible event marker from the privately-held digital health company etectRx, as ...
Posted by Michael Wonder on 10 Dec 2019
New report calls for measurement of outcomes and federal funding for research and increased capacity at FDA to advance safe and effective regenerative cell therapies
10 December 2019 - A new report released by the independent, non-profit Alliance for Cell Therapy Now, highlights the need ...
Posted by Michael Wonder on 10 Dec 2019
Endo launches generic version of Afinitor (everolimus) tablets in the United States
10 December 2019 - Endo International today announced that one of its operating companies, Par Pharmaceutical, has received approval for and ...
Posted by Michael Wonder on 10 Dec 2019
Dermira receives fast track designation from FDA for lebrikizumab for the treatment of atopic dermatitis
10 December 2019 - Dermira today announced that the U.S. FDA has granted fast track designation for lebrikizumab, its novel, investigational treatment ...
Posted by Michael Wonder on 10 Dec 2019
U.S. FDA grants VistaGen Therapeutics fast track designation for PH94B for treatment of social anxiety disorder
10 December 2019 - VistaGen's PH94B is the first drug candidate to be granted U.S. FDA fast track designation for treatment ...
Posted by Michael Wonder on 10 Dec 2019
Do large pharma companies provide drug development innovation? Our analysis says no.
10 December 2019 - Large pharmaceutical companies oppose legislation being considered by Congress to lower the prices of prescription drugs. ...
Posted by Michael Wonder on 10 Dec 2019
Speeding access to new and innovative cancer treatments
8 December 2019 - An emerging measure for predicting cancer treatment outcomes could dramatically speed clinical trials and the approval of ...
Posted by Michael Wonder on 09 Dec 2019
Galderma investigational therapy nemolizumab granted FDA breakthrough therapy designation for the treatment of patients suffering from prurigo nodularis
9 December 2019 - Galderma today announced that the U.S. FDA has granted breakthrough therapy Designation to the investigational therapy ...
Posted by Michael Wonder on 09 Dec 2019
Sesen Bio initiates rolling submission of BLA for Vicinium to FDA
9 December 2019 - --Sesen Bio today announced that on 6 December 2019, the Company initiated the submission of its biologics ...