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RSS FeedPosted by Michael Wonder on 19 Dec 2019
Epizyme submits new drug application to the U.S. FDA for tazemetostat for the treatment of patients with follicular lymphoma
18 December 2019 - Submission marks on-time execution of second submission for tazemetostat in 2019. ...
Posted by Michael Wonder on 18 Dec 2019
Chondrial Therapeutics announces dosing of first patients in Phase 1 clinical program of CTI-1601 for treatment of Friedreich’s ataxia; CTI-1601 granted rare pediatric disease designation and fast track designation by U.S. FDA
18 December 2019 - Chondrial Therapeutics, a clinical-stage biotechnology company focused on developing treatments for rare diseases, with an initial ...
Posted by Michael Wonder on 18 Dec 2019
Orphazyme’s arimoclomol receives US fast track designation in sporadic inclusion body myositis
18 December 2019 - Orphazyme today received fast track designation from the US FDA for the development of arimoclomol for the ...
Posted by Michael Wonder on 18 Dec 2019
FDA approves new type of therapy to treat advanced urothelial cancer
18 December 2019 - Today, the U.S. FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor ...
Posted by Michael Wonder on 18 Dec 2019
Bristol-Myers Squibb announces submission of biologics license application for CAR T-Cell therapy lisocabtagene maraleucel (liso-cel) to FDA
18 December 2019 - Submission includes data from TRANSCEND NHL 001 trial evaluating liso-cel in patients with relapsed or refractory ...
Posted by Michael Wonder on 18 Dec 2019
Seattle Genetics announces U.S. FDA grants breakthrough therapy designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer
18 December 2019 - New drug application submission to U.S. FDA expected by first quarter of 2020. ...
Posted by Michael Wonder on 18 Dec 2019
U.S. FDA acknowledges receipt of Evofem Biosciences' new drug application resubmission for Amphora for the prevention of pregnancy
18 December 2019 - Assigns PDUFA goal date of 25 May 2020. ...
Posted by Michael Wonder on 18 Dec 2019
U.S. FDA accepts and grants priority review to sNDA for Braftovi (encorafenib) in combination with Erbitux (cetuximab) (Braftovi doublet) for the treatment of BRAF V600E-mutant metastatic colorectal cancer after prior therapy
18 December 2019 - Pfizer today announced that the U.S. FDA has accepted and granted priority review to the Company’s supplemental ...
Posted by Michael Wonder on 18 Dec 2019
Trump Administration takes historic steps to lower U.S. prescription drug prices
18 December 2019 - Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers ...
Posted by Michael Wonder on 18 Dec 2019
AbbVie receives European Commission approval of Rinvoq (upadacitinib) for the treatment of adults with moderate to severe active rheumatoid arthritis
18 December 2019 - Approval supported by data from the pivotal Phase 3 SELECT rheumatoid arthritis program evaluating nearly 4,400 patients. ...
Posted by Michael Wonder on 18 Dec 2019
FDA survey finds Americans don’t really understand drug approvals
17 December 2019 - Only about one quarter (25.1%) of Americans understand that a new drug approved by the US ...
Posted by Michael Wonder on 18 Dec 2019
Statement from Anna Abram, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on low-cost biosimilar and interchangeable protein products
17 December 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is ...
Posted by Michael Wonder on 18 Dec 2019
Agios receives FDA breakthrough therapy designation for Tibsovo (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation
16 December 2019 - Agios Pharmaceuticals today announced that the U.S. FDA has granted breakthrough therapy designation for Tibsovo (ivosidenib) for ...
Posted by Michael Wonder on 18 Dec 2019
PharmaMar has filed new drug application for lurbinectedin with the FDA for the treatment of relapsed small cell lung cancer
17 December 2019 - The application is based on the phase II multicenter basket trial data. ...
Posted by Michael Wonder on 18 Dec 2019
Pivotal DREAMM-2 study demonstrated a clinically meaningful overall response rate with belantamab mafodotin (GSK2857916) for patients with relapsed/refractory multiple myeloma
16 December 2019 - GSK confirms submission of a biologics license application to the US FDA. ...