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RSS FeedPosted by Michael Wonder on 02 Jan 2018
FDA accepts supplemental biologics license application and grants priority review for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin's lymphoma
2 January 2018 - Submission based on positive results from the Phase 3 ECHELON-1 clinical trial. ...
Posted by Michael Wonder on 29 Dec 2017
Progenics Pharmaceuticals announces FDA acceptance of new drug application for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
29 December 2017 - Progenics Pharmaceuticals announced today that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 29 Dec 2017
GW Pharmaceuticals announces acceptance of NDA filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
28 December 2017 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 22 Dec 2017
Novartis' combination therapy Tafinlar and Mekinist granted FDA priority review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma
22 December 2017 - Priority review designation based on Phase III study showing 53% reduction in risk of recurrence or death ...
Posted by Michael Wonder on 22 Dec 2017
Basilea reports that ceftobiprole received QIDP designation from U.S. FDA for the treatment of Staphylococcus aureus bacteremia
21 December 2017 - Basilea Pharmaceutica announced today that the U.S. FDA designated its investigational drug ceftobiprole as a Qualified ...
Posted by Michael Wonder on 22 Dec 2017
U.S. FDA grants priority review to Janssen for apalutamide as a treatment for non-metastatic castration-resistant prostate cancer
21 December 2017 - Apalutamide is the first agent submitted for approval to treat earlier stage castration-resistant prostate cancer at high ...
Posted by Michael Wonder on 18 Dec 2017
FDA accepts biologics license application for fremanezumab with priority review for prevention of migraine and grants fast track designation for cluster headache development program
18 December 2017 - Teva anticipates launching anti-CGRP product in the U.S. for the prevention of migraine in 2018. ...
Posted by Michael Wonder on 18 Dec 2017
US FDA accepts regulatory submission for Tagrisso in first-line EGFR-mutated non-small cell lung cancer
18 December 2017 - Tagrisso granted priority review. ...
Posted by Michael Wonder on 14 Dec 2017
U.S. FDA accepts Bristol-Myers Squibb’s application for Opdivo (nivolumab) plus Yervoy (ipilimumab) in intermediate and poor-risk patients with advanced renal cell carcinoma and grants priority review
13 December 2017 - The Opdivo plus Yervoy combination previously received FDA breakthrough therapy designation. ...
Posted by Michael Wonder on 12 Dec 2017
FDA accepts supplemental biologics license application, assigns priority review to Merck’s Keytruda (pembrolizumab) for treatment of relapsed or refractory primary mediastinal large B-cell lymphoma
11 December 2017 - Data for Keytruda in patients with relapsed or refractory PMBCL show overall response rate of 41% ...
Posted by Michael Wonder on 06 Dec 2017
Clovis announces priority review designation for rucaparib supplemental new drug application
5 December 2017 - Priority review granted based on positive data from phase 3 ARIEL3 clinical trial in which rucaparib significantly ...
Posted by Michael Wonder on 29 Nov 2017
BioMarin sells second priority review voucher for 125 million dollars
27 November 2017 - BioMarin today announced that it has entered into a definitive agreement to sell the rare paediatric disease ...
Posted by Michael Wonder on 28 Nov 2017
Kyowa Hakko Kirin announces FDA acceptance for filing and priority review designation of mogamulizumab’s biologics license application
28 November 2017 - Kyowa Hakko Kirin today announces that the U.S. FDA has accepted for review the biologics license ...
Posted by Michael Wonder on 22 Nov 2017
U.S. FDA accepts regulatory submission and grants priority review for US WorldMeds' lofexidine
21 November 2017 - US WorldMeds today announced that the U.S. FDA has accepted and granted priority review of the ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...