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RSS FeedPosted 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 ...
Posted by Michael Wonder on 09 Dec 2019
FDA approving drugs at breakneck speed, raising alarm
7 December 2019 - Breakthrough products beating deadlines by weeks, even months. ...
Posted by Michael Wonder on 09 Dec 2019
Court rules against FDA’s finding that a device was a drug
9 December 2019 - Whether the US FDA classifies a product as a drug or a device can have huge ...
Posted by Michael Wonder on 07 Dec 2019
Janssen announces BCMA CAR-T therapy JNJ-4528 granted U.S. FDA breakthrough therapy designation for the treatment of relapsed or refractory multiple myeloma
6 December 2019 - Newest designation for JNJ-4528 is supported by Phase 1b/2 CARTITUDE-1 study in adults with relapsed or refractory ...
Posted by Michael Wonder on 06 Dec 2019
FDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab)
6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio. ...
Posted by Michael Wonder on 06 Dec 2019
Alector announces FDA fast track designation granted to AL001 for the treatment of patients with frontotemporal dementia
5 December 2019 - Alector today announced that the U.S. FDA has granted fast track designation for its investigational therapeutic, ...
Posted by Michael Wonder on 05 Dec 2019
FDA approves first generics of Gilenya
5 December 2019 - The U.S. FDA has approved three applications for first generics of Gilenya (fingolimod) capsules for the ...