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RSS FeedPosted by Michael Wonder on 06 Aug 2021
Formycon and Bioeq announce submission of the biologics license application for FYB201, a biosimilar candidate to Lucentis (ranibizumab) to the U.S. FDA
5 August 2021 - Formycon and its license partner Bioeq announce that the biologics license application for FYB201, Formycon’s biosimilar ...
Posted by Michael Wonder on 06 Aug 2021
Altoida awarded FDA breakthrough designation for development of world’s first precision neurology device for prediction of Alzheimer's disease
5 August 2021 - Breakthrough designation will advance the development of industry’s first predictive diagnostic device for conversion to Alzheimer’s disease, ...
Posted by Michael Wonder on 05 Aug 2021
Exelixis announces U.S. FDA accepts for priority review the supplemental new drug application for Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory differentiated thyroid cancer
5 August 2021 - U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of 4 December ...
Posted by Michael Wonder on 05 Aug 2021
Pillar Biosciences receives premarket approval from FDA for its oncoReveal Dx lung and colon cancer assay
5 August 2021 - Pillar Biosciences today announced the U.S. FDA has given premarket approval to its oncoReveal Dx Lung ...
Posted by Michael Wonder on 05 Aug 2021
Eiger announces FDA breakthrough therapy designation for avexitide for treatment of congenital hyperinsulinism
5 August 2021 - All five orphan programs now have breakthrough therapy designation. ...
Posted by Michael Wonder on 05 Aug 2021
From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...
Posted by Michael Wonder on 05 Aug 2021
MT-3921 granted FDA fast track designation for treatment of spinal cord injury
4 August 2021 - Mitsubishi Tanabe Pharma announced today that Mitsubishi Tanabe Pharma Development America has received fast track designation ...
Posted by Michael Wonder on 04 Aug 2021
Federal watchdog will review the controversial FDA approval of Biogen’s Alzheimer’s drug
4 August 2021 - The federal watchdog at the Department of Health and Human Services will review the process used ...
Posted by Michael Wonder on 04 Aug 2021
Kestra Medical Technologies receives FDA premarket approval for ASSURE wearable cardioverter defibrillator
3 August 2021 - Kestra Medical Technologies announced today that the company has received U.S. FDA premarket approval for the ASSURE ...
Posted by Michael Wonder on 04 Aug 2021
Collecting patient reported outcomes in cancer clinical trials
3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...
Posted by Michael Wonder on 04 Aug 2021
FDA reportedly hopes to fully approve Pfizer’s Covid vaccine by Labor Day
3 August 2021 - Federal regulators are aiming to grant full approval to Pfizer’s coronavirus vaccine by early September, the New ...
Posted by Michael Wonder on 04 Aug 2021
Interpreting the results of intention to treat, per protocol and as treated analyses of clinical trials
3 August 2021 - Non-adherence in a randomised clinical trial occurs when study participants do not follow the randomly assigned treatment ...
Posted by Michael Wonder on 04 Aug 2021
FDA regulation and approval of medical devices: 1976-2020
3 August 2021 - US law generally requires testing of high-risk medical devices prior to approval, as well as pre-market evaluation ...
Posted by Michael Wonder on 04 Aug 2021
FDA grants breakthrough device designation status for Hancock Jaffe's VenoValve
3 August 2021 - VenoValve is a potential treatment for approximately 2.4 million U.S. patients that suffer from severe chronic venous ...
Posted by Michael Wonder on 04 Aug 2021
Abbott receives FDA clearance for its imaging technology using artificial intelligence for vessels in the heart
3 August 2021 - Ultreon 1.0 software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using ...