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RSS FeedPosted by Michael Wonder on 24 Feb 2020
Takeda announces U.S. FDA grants priority review for supplemental new drug application for Alunbrig (brigatinib) as a first-line treatment for ALK+ metastatic non-small cell lung cancer
25 February 2020 - Prescription Drug User Fee Act target action date set for 23 June 2020. ...
Posted by Michael Wonder on 19 Feb 2020
U.S. FDA accepts Karyopharm’s supplemental new drug application for Xpovio (selinexor) as a treatment for patients with relapsed or refractory diffuse large B cell lymphoma
19 February 2020 - Priority review granted; user fee goal date set for 23 June 2020. ...
Posted by Michael Wonder on 19 Feb 2020
FDA grants priority review to Genentech’s Tecentriq monotherapy as first-line treatment of certain people with advanced non-small cell lung cancer
18 February 2020 - Genentech today announced that the U.S. FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 19 Feb 2020
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for Padcev (enfortumab vedotin-ejfv) in combination with pembrolizumab in first-line advanced bladder cancer
19 February 2020 - Breakthrough therapy designation based on initial results from Phase 1b/2 EV-103 clinical trial. ...
Posted by Michael Wonder on 19 Feb 2020
Merck receives complete response letter from the US FDA for supplemental biologics license applications for Keytruda (pembrolizumab) six-week dosing schedule
18 February 2020 - Merck today announced that the U.S. FDA has issued a complete response letter regarding Merck’s supplemental biologics ...
Posted by Michael Wonder on 19 Feb 2020
Understanding the role of comparative clinical studies in the development of oncology biosimilars
14 February 2020 - Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care ...
Posted by Michael Wonder on 18 Feb 2020
ALX Oncology’s ALX148 receives two fast track designations from FDA for the treatment of patients with head and neck squamous cell carcinoma and patients with gastric or gastro-esophageal junction adenocarcinoma
18 February 2020 - ALX Oncology today announced that the U.S. FDA has granted two fast track designations for its lead ...
Posted by Michael Wonder on 18 Feb 2020
PharmaMar and Jazz Pharmaceuticals announce FDA acceptance and priority review of new drug application for lurbinectedin in relapsed small cell lung cancer
17 February 2020 - Prescription Drug User Fee Act date set for 16 August 2020. ...
Posted by Michael Wonder on 14 Feb 2020
Epizyme announces FDA acceptance of new drug application for filing with priority review for Tazverik (tazemetostat) for the treatment of follicular lymphoma
14 February 2020 - Approval would expand Tazverik label into second indication. ...
Posted by Michael Wonder on 14 Feb 2020
Seattle Genetics announces FDA filing acceptance for priority review of tucatinib new drug application for patients with locally advanced or metastatic HER2-positive breast cancer
13 February 2020 - FDA Action Date is 20 August 2020; Application under FDA’s real-time oncology review and Orbis pilot programs. ...
Posted by Michael Wonder on 13 Feb 2020
U.S. FDA accepts for priority review Bristol-Myers Squibb’s biologics license application for lisocabtagene maraleucel (liso-cel) for adult patients with relapsed or refractory large B cell lymphoma
13 February 2020 - Application based on results from the TRANSCEND NHL 001 trial, the largest study of CD19-directed CAR T ...
Posted by Michael Wonder on 13 Feb 2020
Deciphera Pharmaceuticals announces U.S. FDA acceptance of new drug application and priority review for ripretinib in patients with advanced gastro-intestinal stromal tumour
12 February 2020 - FDA grants priority review and sets PDUFA date of 13 August 2020. ...
Posted by Michael Wonder on 12 Feb 2020
Astex Pharmaceuticals announces U.S. FDA acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML
11 February 2020 - FDA designated the application for priority review. ...
Posted by Michael Wonder on 11 Feb 2020
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
11 February 2020 - Capmatinib review expected to be completed within six months. ...
Posted by Michael Wonder on 11 Feb 2020
Janssen announces submission to U.S. FDA for new Darzalex (daratumumab)-based combination regimen for patients with relapsed/refractory multiple myeloma
10 February 2020 - Application is based on positive data from the Phase 3 CANDOR study, which were presented at the ...