Blog
RSS FeedPosted by Michael Wonder on 06 Nov 2018
Poseida Therapeutics receives regenerative medicine advanced therapy designation from FDA for P-BCMA-101
5 November 2018 - Poseida Therapeutics today announced the U.S. FDA has granted a regenerative medicine advanced therapy designation to P-BCMA-101, ...
Posted by Michael Wonder on 31 Oct 2018
FDA grants priority review for Sanofi's dengue vaccine candidate
31 October 2018 - The United States FDA has accepted a biologics license application for Sanofi Pasteur's dengue vaccine. ...
Posted by Michael Wonder on 28 Oct 2018
FDA accepts supplemental new drug application for Lonsurf (trifluridine/tipiracil) for the treatment of metastatic gastric/gastro-oesophageal junction adenocarcinoma; grants priority review
26 October 2018 - Taiho Pharmaceutical today announced that the United States FDA has accepted and granted priority review for ...
Posted by Michael Wonder on 25 Oct 2018
FDA grants priority review for ruxolitinib (Jakafi) as a treatment for patients with acute graft-versus-host disease
25 October 2018 - Incyte today announced that the U.S. FDA has accepted for priority review its supplemental new drug ...
Posted by Michael Wonder on 22 Oct 2018
Eiger BioPharmaceuticals receives FDA rare paediatric disease designation for lonafarnib for the treatment of progeria and progeroid laminopathies and plans NDA filing in 2019
22 October 2018 - Designation enables priority review voucher eligibility upon NDA approval. ...
Posted by Michael Wonder on 18 Oct 2018
Immusoft receives rare paediatric disease designation for treatment of MPS I
17 October 2018 - Company seeks to use engineered B cells to deliver missing enzyme for patients. ...
Posted by Michael Wonder on 17 Oct 2018
AbbVie announces supplemental new drug application accepted for priority review by U.S. FDA for Imbruvica (ibrutinib) in combination with obinutuzumab (Gazyva) for previously untreated chronic lymphocytic leukaemia
17 October 2018 - The submission is based on positive results from the Phase 3 iLLUMINATE (PCYC-1130) trial, which showed longer ...
Posted by Michael Wonder on 12 Oct 2018
Spero Therapeutics receives QIDP designation from the U.S. FDA for the development of SPR206
11 October 2018 - Spero Therapeutics announced today that SPR206, a product candidate within Spero’s Potentiator Platform, has been granted qualified ...
Posted by Michael Wonder on 06 Oct 2018
U.S. FDA accepts Karyopharm’s new drug application for selinexor and grants priority review
5 October 2018 - Application seeks accelerated approval for selinexor as a treatment for patients with penta-refractory multiple myeloma. ...
Posted by Michael Wonder on 02 Oct 2018
FDA grants rare paediatric disease designation to pegzilarginase for arginase 1 deficiency
1 October 2018 - Aeglea eligible to receive a priority review voucher. ...
Posted by Michael Wonder on 26 Sep 2018
FDA grants QIDP and fast track designations to Cidara Therapeutics’ rezafungin prophylaxis development program
25 September 2018 - Rezafungin designated for the prevention of invasive fungal infections in adults undergoing bone marrow transplantation. ...
Posted by Michael Wonder on 18 Sep 2018
FDA grants Lin BioScience rare paediatric disease status for LBS-008 to treat Stargardt disease
17 September 2018 - Designation enhances FDA orphan drug designation for Phase I candidate targeting incurable blindness in children. ...
Posted by Michael Wonder on 17 Sep 2018
FDA grants rare paediatric disease designation to Cellectar Biosciences’ CLR 131 for the treatment of osteosarcoma
17 September 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131 ...
Posted by Michael Wonder on 13 Sep 2018
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumours express PD-L1 (TPS ≥1%)
12 September 2018 - Application Based on Overall Survival Data from Pivotal Phase 3 KEYNOTE-042 Trial. ...
Posted by Michael Wonder on 04 Sep 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of Merkel cell carcinoma, a rare form of skin cancer
4 September 2018 - Application based on data from Phase 2 KEYNOTE-017 trial. ...