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RSS FeedPosted by Michael Wonder on 27 Feb 2019
Celgene Corporation announces key regulatory update for Revlimid in lymphoma
26 February 2019 - U.S. FDA grants priority review for Revlimid (lenalidomide) in combination with rituximab for previously treated follicular and ...
Posted by Michael Wonder on 26 Feb 2019
Spero Therapeutics receives QIDP designation from the U.S. FDA for the development of SPR720
26 February 2019 - Phase 1 top-line data readout for oral SPR720 expected in second half of 2019. ...
Posted by Michael Wonder on 23 Feb 2019
FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder
22 February 2019 - FDA sets action date of 28 June 2019. ...
Posted by Michael Wonder on 20 Feb 2019
Agios announces FDA acceptance of supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an IDH1 mutation not eligible for standard therapy
20 February 2019 - PDUFA date set for June 21 2019. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) monotherapy for third-line treatment of patients with advanced small cell lung cancer
20 February 2019 - Marks first application for Keytruda in SCLC. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Roche’s polatuzumab vedotin in previously treated aggressive lymphoma
19 February 2019 - Polatuzumab vedotin has shown significant potential to improve outcomes in people living with this disease. ...
Posted by Michael Wonder on 19 Feb 2019
FDA grants priority review to Roche’s personalised medicine entrectinib
19 February 2019 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug ...
Posted by Michael Wonder on 19 Feb 2019
AbbVie announces new drug application accepted for priority review by U.S. FDA for upadacitinib for treatment of moderate to severe rheumatoid arthritis
19 February 2019 - AbbVie used a priority review voucher to expedite review of the upadacitinib NDA. ...
Posted by Michael Wonder on 16 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for advanced renal cell carcinoma
15 February 2019 - Application based on overall survival and progression-free survival data from Phase 3 KEYNOTE-426 trial. ...
Posted by Michael Wonder on 15 Feb 2019
Sarepta announces FDA acceptance of golodirsen (SRP-4053) new drug application for patients with Duchenne muscular dystrophy amenable to skipping exon 53
14 February 2019 - FDA grants priority review status. ...
Posted by Michael Wonder on 11 Feb 2019
FDA accepts sBLA and grants priority review for Bavencio (avelumab) plus Inlyta (axitinib) for the treatment of advanced renal cell carcinoma
11 February 2019 - Merck and Pfizer today announced that the US FDA has accepted for priority review the supplemental biologics ...
Posted by Michael Wonder on 11 Feb 2019
Clementia granted rare paediatric disease designation by FDA for palovarotene for fibrodysplasia ossificans progressiva
11 February 2019 - Clementia Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to palovarotene for ...
Posted by Michael Wonder on 11 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma
11 February 2019 - Filing includes use of Keytruda in the first-line setting as monotherapy or in combination with chemotherapy. ...
Posted by Michael Wonder on 11 Feb 2019
RegenxBio receives rare paediatric disease designation for RGX-181 gene therapy for the treatment of CLN2 form of Batten disease
31 January 2019 - Novel, one-time investigational treatment for CLN2 disease designed to halt progression of this rare, paediatric, neurodegenerative disease. ...
Posted by Michael Wonder on 31 Jan 2019
Xenon provides key regulatory updates on XEN007 and XEN1101
28 January 2019 - FDA grants rare paediatric disease designation to XEN007 for alternating hemiplegia of childhood. ...