Blog
RSS FeedPosted by Michael Wonder on 18 Aug 2020
Imfinzi granted FDA priority review for less-frequent, fixed-dose use
18 August 2020 - Option would extend dosing to four weeks in non-small cell lung and bladder cancer reducing medical visits ...
Posted by Michael Wonder on 17 Aug 2020
Clinical trials of coronavirus drugs are taking longer than expected
14 August 2020 - Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a ...
Posted by Michael Wonder on 17 Aug 2020
Acute myeloid leukaemia: developing drugs and biological products for treatment
17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological ...
Posted by Michael Wonder on 17 Aug 2020
Myovant Sciences announces FDA acceptance of new drug application for once daily relugolix combination tablet for uterine fibroids
17 August 2020 - FDA sets target action date of 1 June 2021. ...
Posted by Michael Wonder on 17 Aug 2020
G1 Therapeutics announces acceptance and priority review of NDA for trilaciclib for patients with small cell lung cancer
17 August 2020 - G1 launching expanded access program for patients with small cell lung cancer in the U.S.. ...
Posted by Michael Wonder on 17 Aug 2020
United Therapeutics announces U.S. FDA filing acceptance of supplemental new drug application for Tyvaso for pulmonary hypertension associated with interstitial lung disease
17 August 2020 - United Therapeutics today announced that the U.S. FDA accepted for review the supplemental new drug application ...
Posted by Michael Wonder on 15 Aug 2020
FDA approves Genentech’s Enspryng for neuromyelitis optica spectrum disorder
14 August 2020 - First and only FDA approved subcutaneous treatment option for anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder that ...
Posted by Michael Wonder on 15 Aug 2020
Valuing innovative drugs based on their cost of manufacturing will prolong the COVID-19 pandemic
14 August 2020 - The value of innovative medicines has absolutely nothing to do with its cost of production. Yet, ...
Posted by Michael Wonder on 14 Aug 2020
ANTI-PD-1/CTLA-4 bi-specific antibody (AK104) of Akeso granted FDA fast track designation for recurrent and metastatic cervical cancer
13 August 2020 - Akeso today announced that the U.S. FDA has granted fast track designation for AK104, a novel anti-PD-1/CTLA-4 ...
Posted by Michael Wonder on 13 Aug 2020
4D Molecular Therapeutics receives FDA fast track designation for 4D-310 gene therapy for treatment of Fabry disease
13 August 2020 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation to 4D-310 for ...
Posted by Michael Wonder on 13 Aug 2020
TG Therapeutics announces FDA acceptance of new drug application for umbralisib as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma
13 August 2020 - TG Therapeutics today announced that the U.S. FDA has accepted the Company’s new drug application for umbralisib, ...
Posted by Michael Wonder on 13 Aug 2020
Novartis announces FDA filing acceptance of Xolair (omalizumab) pre-filled syringe for self-administration across all indications
13 August 2020 - If approved, Xolair self-administration would offer a more flexible option to help select patients manage their treatment ...
Posted by Michael Wonder on 12 Aug 2020
US hoses down Russian vaccine, says it will have millions of doses ready year's end
12 August 2020 - US Health Secretary Alex Azar has criticised a COVID-19 vaccine being promoted by Russian President Vladimir ...
Posted by Michael Wonder on 12 Aug 2020
FDA accepts evinacumab biologics license application for priority review as a treatment for patients with HoFH, an ultra-rare inherited form of high cholesterol
12 August 2020 - Homozygous familial hypercholesterolaemia affects approximately 1,300 patients in the U.S., the vast majority of whom are unable ...
Posted by Michael Wonder on 12 Aug 2020
Moderna announces supply agreement with U.S. Government for initial 100 million doses of mRNA vaccine against COVID-19 (mRNA-1273)
11 August 2020 - New U.S. government award up to $1.525 billion for 100 million doses. ...