Blog
RSS FeedPosted by Michael Wonder on 31 Jul 2019
FDA approves new monotherapy indication for Merck’s Keytruda (pembrolizumab)
31 July 2019 - Keytruda now approved for recurrent locally advanced or metastatic squamous cell carcinoma of the oesophagus in patients ...
Posted by Michael Wonder on 31 Jul 2019
U.S. FDA approves darolutamide, a new treatment for men with non-metastatic castration-resistant prostate cancer
31 July 2019 - Darolutamide was approved in the U.S. under the FDA priority review designation; approval granted three months ahead ...
Posted by Michael Wonder on 26 Jul 2019
Surrogate endpoints in randomised controlled trials: a reality check
27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI ...
Posted by Michael Wonder on 25 Jul 2019
Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat for the treatment of epithelioid sarcoma
25 July 2019 - Company aligns with FDA on planned confirmatory study design for tazemetostat in epithelioid sarcoma. ...
Posted by Michael Wonder on 23 Jul 2019
Merck and Eisai receive third breakthrough therapy designation from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination treatment
23 July 2019 - Designation granted for potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to loco-regional ...
Posted by Michael Wonder on 23 Jul 2019
Imfinzi (durvalumab) US label updated with overall survival data in unresectable, Stage III non-small cell lung cancer
22 July 2019 - Imfinzi is the only immunotherapy approved to treat patients in this curative-intent setting following chemoradiation therapy. ...
Posted by Michael Wonder on 16 Jul 2019
Seattle Genetics and Astellas announce submission of biologics license application to FDA for enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer
16 July 2019 - Submission based on pivotal Phase 2 trial results recently presented at Annual Meeting of American Society of ...
Posted by Michael Wonder on 13 Jul 2019
Janssen submits application to U.S. FDA seeking approval of new Darzalex (daratumumab) subcutaneous formulation
12 July 2019 - Submission inclusive of data from Phase 3 COLUMBA study presented at ASCO. ...
Posted by Michael Wonder on 10 Jul 2019
FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma
10 July 2019 - The U.S. FDA has accepted for review the biologics license application for isatuximab for the treatment ...
Posted by Michael Wonder on 10 Jul 2019
Cellectar receives FDA fast track designation for CLR 131 in diffuse large B-cell lymphoma
9 July 2019 - Cellectar Biosciences today announced the U.S. FDA has granted fast track designation for CLR 131 in relapsed ...
Posted by Michael Wonder on 09 Jul 2019
FDA accepts Merck’s supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule for melanoma and multiple other indications
9 July 2019 - Merck today announced that the U.S. FDA has accepted for review six supplemental biologics license applications to ...
Posted by Michael Wonder on 09 Jul 2019
The fragility of phase 3 trials supporting FDA approved anti-cancer medicines: a retrospective analysis
8 July 2019 - The fragility index of trial results—ie, the minimum number of changes from non-events to events resulting in ...
Posted by Michael Wonder on 07 Jul 2019
Fast-track drug approval, designed for emergencies, is now routine
5 July 2019 - Three-quarters of new drugs get an expedited regulatory review, thrusting families and doctors into a new world ...
Posted by Michael Wonder on 04 Jul 2019
Karyopharm Therapeutics prices blood cancer treatment after FDA approval
4 July 2019 - Karyopharm Therapeutics has set a list-price for its blood cancer treatment Xpovio at $22,000 per month, ...
Posted by Michael Wonder on 03 Jul 2019
FDA approves new treatment for refractory multiple myeloma
3 July 2019 - Today, the U.S. FDA granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone ...