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RSS FeedPosted by Michael Wonder on 07 Nov 2019
U.S. FDA approves enhanced formulation of Pliaglis
5 November 2019 - Crescita Therapeutics today announced that the U.S. FDA approved the enhanced formulation of Pliaglis® (the "Enhanced Formulation") ...
Posted by Michael Wonder on 07 Nov 2019
Endoceutics receives Health Canada approval for Intrarosa
6 November 2019 - The first innovative drug for the treatment of vulvovaginal atrophy with prasterone. ...
Posted by Michael Wonder on 07 Nov 2019
Statement on the agency’s efforts to protect patients through post-market drug safety surveillance practices
6 November 2019 - Public health and safety is the highest priority at the U.S. FDA. ...
Posted by Michael Wonder on 06 Nov 2019
Dr. Stephen Hahn nominated to be next FDA commissioner
6 November 2019 - The Trump administration on Tuesday formally nominated Dr. Stephen Hahn to be the next commissioner of ...
Posted by Michael Wonder on 06 Nov 2019
Innovation and access at the mercy of payment policy: the future of chimeric antigen receptor therapies
1 November 2019 - In 2017, the US FDA approved the first chimeric antigen receptor therapies (CAR-Ts), tisagenlecleucel and axicabtagene ...
Posted by Michael Wonder on 06 Nov 2019
Novartis says delayed telling FDA of Zolgensma concern due to 'mistake'
2 November 2019 - Novartis scientists learnt months ago about safety concerns surrounding its gene therapy Zolgensma but delayed telling the ...
Posted by Michael Wonder on 06 Nov 2019
FDA Office of Hematology Oncology Products reorganises, renamed Office of Oncologic Diseases
6 November 2019 - The U.S. FDA’s office responsible for reviewing applications for new and existing cancer therapies has reorganized ...
Posted by Michael Wonder on 06 Nov 2019
Bionomics announces fast track designation granted by U.S. FDA to BNC210 development program for the treatment of PTSD
4 November 2019 - Bionomics announced today that the U.S. FDA has granted fast track designation to the BNC210 development program ...
Posted by Michael Wonder on 06 Nov 2019
One shot drug to end Sicilian curse comes at $1.8 million cost
5 November 2019 - A new targeted gene therapy shows the promise and pitfalls of medical advances. ...
Posted by Michael Wonder on 06 Nov 2019
Octapharma’s fibryga receives European label extension to treat acquired fibrinogen deficiency (AFD)
5 November 2019 - Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of ...
Posted by Michael Wonder on 06 Nov 2019
FDA authorises marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations
5 November 2019 - Today, the U.S. FDA authorised marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug ...
Posted by Michael Wonder on 06 Nov 2019
Is the FDA doing enough to bring biosimilars to market?
4 November 2019 - As the number of biosimilar approvals continues to rise in the US, the number of biosimilar ...
Posted by Michael Wonder on 05 Nov 2019
A severe shortage hits a drug used for cancer, immune disorders, epilepsy, causing canceled treatments and rationing
5 November 2019 - A severe shortage of immune globulin — a popular medicine used to treat epilepsy, cancer and ...
Posted by Michael Wonder on 05 Nov 2019
GE Healthcare announces U.S. FDA approval of macrocyclic MRI contrast agent Clariscan (gadoterate meglumine) injection for intravenous use
4 November 2019 - Clariscan, approved in more than 55 countries globally with over four million patient doses shipped, is now ...
Posted by Michael Wonder on 05 Nov 2019
FDA approves Fluzone High-Dose quadrivalent (influenza vaccine) for adults 65 years of age and older
4 November 2019 - Will be available in fall 2020, in time for the 2020-2021 flu season. ...