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RSS FeedPosted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...
Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure
20 January 2021 - Vericiguat (Verquvo) is the first soluble guanylate cyclase stimulator to be approved for the treatment of symptomatic ...
Posted by Michael Wonder on 19 Jan 2021
Taysha Gene Therapies receives rare paediatric disease and orphan drug designations for TSHA-105 for the treatment of epilepsy caused by SLC13A5 deficiency
19 January 2021 - Designations reinforce unmet need for treatment options for patients with rare form of genetic epilepsy. ...
Posted by Michael Wonder on 19 Jan 2021
Biologics license application for narsoplimab in HSCT-TMA accepted for priority review by U.S. FDA
19 January 2021 - FDA sets PDUFA date of 17 July 2021. ...
Posted by Michael Wonder on 19 Jan 2021
Occlutech's atrial flow regulator receives U.S. FDA breakthrough device designation for heart failure
19 January 2021 - Occlutech announced today that the U.S FDA has granted the Company a breakthrough revice designation for its ...
Posted by Michael Wonder on 19 Jan 2021
Metacrine announces FDA fast track designation for MET642 as a treatment of NASH
19 January 2021 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET642, the company’s second ...
Posted 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 ...