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RSS FeedPosted by Michael Wonder on 16 Jan 2018
Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA
16 January 2018 - The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference ...
Posted by Michael Wonder on 16 Jan 2018
Teva announces U.S. FDA approval of Trisenox (arsenic trioxide) injection for first-line treatment of acute promyelocytic leukaemia
15 January 2018 - Teva Pharmaceutical Industries announced that the U.S. FDA has approved the use of Trisenox (arsenic trioxide) injection ...
Posted by Michael Wonder on 14 Jan 2018
Can your hip replacement kill you?
13 January 2018 - When Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an ...
Posted by Michael Wonder on 13 Jan 2018
Cour Pharmaceuticals receives FDA fast track designation for TIMP-GLIA
8 January 2018 - TIMP-GLIA is designed to enable patients to develop tolerance to gluten. ...
Posted by Michael Wonder on 13 Jan 2018
FDA grants fast track designation to Concert Pharmaceuticals' CTP-543 for the treatment of alopecia areata
12 January 2018 - CTP-543 is a novel JAK inhibitor in Phase 2 for alopecia areata as potential first-in-class treatment. ...
Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research ...
Posted by Michael Wonder on 13 Jan 2018
Statement from FDA Commissioner on FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products
12 January 2018 - The FDA is committed to ensuring that we have the right policies and processes in place ...
Posted by Michael Wonder on 13 Jan 2018
FDA approves first treatment for breast cancer with a certain inherited genetic mutation
12 January 2018 - The U.S. FDA today expanded the approved use of Lynparza (olaparib) to include the treatment of patients ...
Posted by Michael Wonder on 11 Jan 2018
Many “firsts” for CDER’s 2017 drug approvals reflect innovation and enhanced patient care
10 January 2018 - In 2017, FDA’s Center for Drug Evaluation and Research approved many new drugs never before marketed in ...
Posted by Michael Wonder on 11 Jan 2018
ObamaCare repeal fades from GOP priorities list in new year
10 January 2018 - The chances of repealing ObamaCare this year are fading further, with top Republicans saying they hardly ...
Posted by Michael Wonder on 11 Jan 2018
New guidance: When can the FDA refuse to file NDAs and BLAs?
10 January 2018 - According to US FDA regulations, the regulatory agency may refuse to file a new drug application ...
Posted by Michael Wonder on 10 Jan 2018
The health 202: This year's top 10 new drugs
9 January 2018 - Yes, overall spending on prescription drugs has slowed recently, but expect Democrats to pummel Alex Azar ...
Posted by Michael Wonder on 09 Jan 2018
Eisai and Merck receive breakthrough therapy designation from U.S. FDA for Lenvima (lenvatinib mesylate) and Keytruda (pembrolizumab) as combination therapy for advanced and/or metastatic renal cell carcinoma
9 January 2018 - Eisai and Merck announced today that they received breakthrough therapy designation from the U.S. FDA for Eisai’s ...
Posted by Michael Wonder on 09 Jan 2018
GBT receives FDA breakthrough therapy designation for voxelotor for treatment of sickle cell disease
9 January 2018 - Voxelotor is first investigational treatment for sickle cell disease to receive breakthrough therapy designation. ...
Posted by Michael Wonder on 09 Jan 2018
Reflections on a landmark year for medical product innovation and public health advances and looking ahead to policy in 2018
9 January 2018 - As we look ahead to 2018, I’d like to take a moment to reflect on an ...