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RSS FeedPosted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 16 Jan 2021
FDA grants accelerated approval to Darzalex Faspro for newly diagnosed light chain amyloidosis
15 January 2021 - Today, the FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech) in combination ...
Posted by Michael Wonder on 16 Jan 2021
FDA approves fam-trastuzumab deruxtecan-nxki for HER2 positive gastric adenocarcinomas
15 January 2021 - Today, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or ...
Posted by Michael Wonder on 15 Jan 2021
FDA grants fast track designation to padeliporfin ImPACT for Steba biotech
15 January 2021 - Ambitious development program for multiple solid tumours with high unmet need, starting with low grade upper tract ...
Posted by Michael Wonder on 15 Jan 2021
Pfizer's Xalkori (crizotinib) approved by FDA for ALK positive anaplastic large cell lymphoma in children and young adults
14 January 2021 - Xalkori is the first biomarker driven therapy for relapsed or refractory ALCL in young people. ...
Posted by Michael Wonder on 15 Jan 2021
Funding of pharmaceutical innovation during and after the COVID-19 pandemic
14 January 2021 - The COVID-19 pandemic has highlighted the available mechanisms for funding research, development, manufacturing, and distribution in the ...
Posted by Michael Wonder on 14 Jan 2021
Inhibrx granted fast track designation for INBRX-109 for the treatment of unresectable or metastatic conventional chondrosarcoma patients
13 January 2020 - Registration enabling study expected to begin dosing in the second or third quarter of this year. ...
Posted by Michael Wonder on 14 Jan 2021
Pfizer boosts its COVID-19 vaccine output by 2 billion doses
14 January 2021 - The head of pharmaceutical giant Pfizer says its has produced more of its Covid vaccine than ...
Posted by Michael Wonder on 14 Jan 2021
Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA fast track designation
14 January 2021 - Innovation Pharmaceuticals is pleased to announce that the U.S. FDA has designated as a fast track development ...
Posted by Michael Wonder on 14 Jan 2021
FDA veteran Woodcock being considered to lead agency under Biden
14 January 2021 - Joshua Sharfstein, former Obama FDA official, also in running. ...
Posted by Michael Wonder on 14 Jan 2021
Novartis ligelizumab (QGE031) receives FDA breakthrough therapy designation for patients with chronic spontaneous urticaria
14 January 2021 - Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria in patients ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 14 Jan 2021
Workshop on evaluating RWE from observational studies in regulatory decision-making
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
Posted by Michael Wonder on 14 Jan 2021
Amneal launches generic abiraterone acetate 500 mg tablets following ANDA approval by FDA
8 January 2021 - Amneal Pharmaceuticals announced that it has received approval of an additional strength of 500 mg to its ...
Posted by Michael Wonder on 13 Jan 2021
Cognito Therapeutics receives FDA breakthrough device designation for next-generation digital therapeutic in Alzheimer’s disease
12 January 2021 - Breakthrough designation is based on positive outcomes from clinical studies, and will advance the industry’s first next-generation ...