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RSS FeedPosted by Michael Wonder on 18 Sep 2017
Janssen submits supplemental new drug application to U.S. FDA for Zytiga (abiraterone acetate) to treat men with earlier stages of metastatic prostate cancer
14 September 2017 - Filing supported by data from pivotal LATITUDE trial evaluating Zytiga in combination with prednisone and androgen deprivation ...
Posted by Michael Wonder on 17 Sep 2017
Sunovion’s Aptiom (eslicarbazepine acetate) receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older
14 September 2017 - Aptiom provides an important new treatment option for children and adolescents four to 17 years of age ...
Posted by Michael Wonder on 17 Sep 2017
Cheaper drug trials would lower prices: FDA chief
15 September 2017 - Decreasing the time and cost it takes to develop a drug would lower drug prices, FDA ...
Posted by Michael Wonder on 17 Sep 2017
CSL Behring announces FDA approval of Privigen [immune globulin intravenous (human), 10% liquid] for the treatment of chronic inflammatory demyelinating polyneuropathy in adults
14 September 2017 - Privigen shown to improve functional abilities in patients with a rare neurological condition. ...
Posted by Michael Wonder on 14 Sep 2017
Tragedy, perseverance, and chance — the story of CAR-T therapy
13 September 2017 - In 2010, 5-year-old Emily Whitehead was diagnosed with acute lymphoblastic leukaemia. Though her parents were told that ...
Posted by Michael Wonder on 14 Sep 2017
FDA permits marketing of mobile medical application for substance use disorder
14 September 2017 - Today, the U.S. FDA permitted marketing of the first mobile medical application to help treat substance use ...
Posted by Michael Wonder on 14 Sep 2017
Teva receives FDA priority review for first line use of Trisenox (arsenic trioxide) in patients with low to intermediate risk acute promyelocytic leukaemia
12 September 2017 - Teva Pharmaceutical Industries announced today the U.S. FDA has accepted for review the company’s supplemental new ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves new treatment for adults with relapsed follicular lymphoma
14 September 2017 - The U.S. FDA today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed ...
Posted by Michael Wonder on 14 Sep 2017
FDA approves first biosimilar for the treatment of cancer
14 September 2017 - Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and ...
Posted by Michael Wonder on 13 Sep 2017
FDA’s Gottlieb plans to close an orphan drug loophole
12 September 2017 - Amid rising complaints that drug makers are exploiting loopholes to win approval of so-called orphan drugs, ...
Posted by Michael Wonder on 13 Sep 2017
KemPharm announces FDRR process completion and resubmission of the Apadaz NDA
12 September 2017 - FDA has assigned a PDUFA action date of 23 February 2018. ...
Posted by Michael Wonder on 13 Sep 2017
Array BioPharma announces FDA acceptance for review of binimetinib and encorafenib new drug applications for patients with advanced BRAF-mutant melanoma
12 September 2017 - Array BioPharma today announced that the U.S. FDA has accepted for review its new drug applications to ...
Posted by Michael Wonder on 12 Sep 2017
Shire receives FDA fast track designation for SHP607 for the prevention of chronic lung disease in extremely premature infants
12 September 2017 - Shire today announced that the United States FDA has granted fast track designation for SHP607 for ...
Posted by Michael Wonder on 12 Sep 2017
FDA is advancing the goals of the Orphan Drug Act
12 September 2017 - Three months ago, I committed to fully eliminate a backlog of about 200 orphan drug designation requests ...
Posted by Michael Wonder on 12 Sep 2017
Streamlined FDA reviews fail to catch dangerous glitches in health software, study finds
12 September 2017 - The FDA carefully polices many categories of drugs and devices. ...