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RSS FeedPosted by Michael Wonder on 24 Feb 2020
U.S. FDA accepts GSK’s application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer
24 February 2020 - Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib ...
Posted 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 24 Feb 2020
Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis
24 February 2020 - Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and ...
Posted by Michael Wonder on 21 Feb 2020
BioMarin's biologics license application for valoctocogene roxaparvovec accepted for priority review by FDA with review action date of 21 August 2020
20 February 2020 - No advisory committee meeting currently planned to review the application. ...
Posted by Michael Wonder on 20 Feb 2020
Heron Therapeutics announces FDA extension of review period for NDA for HTX-011 for the management of post-operative pain
19 February 2020 - Updated Prescription Drug User Fee Act goal date is 26 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
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 18 Feb 2020
FDA accepts BioCryst’s NDA for oral, once daily berotralstat (BCX7353) to prevent HAE attacks
18 February 2020 - PDUFA date is 3 December 2020. ...
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
Diurnal Group’s new drug application accepted by the US FDA
13 February 2020 - Diurnal Group announced on Thursday that the US FDA accepted its new drug application for review. ...
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
NDA accepted for filing by the FDA for antisense oligonucleotide viltolarsen
7 February 2020 - Nippon Shinyaku announced today that the U.S. FDA has accepted the filing of our new drug ...