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RSS FeedPosted by Michael Wonder on 21 Jan 2021
Biden appoints veteran Woodcock as interim FDA commissioner
21 January 2021 - Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden ...
Posted by Michael Wonder on 21 Jan 2021
FDA grants priority review to Genentech’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
21 January 2021 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...
Posted 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 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 ...