Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 12 Aug 2020
Theranexus and BBDF obtain orphan drug designation and rare paediatric disease designation from the FDA for BBDF-101 for Batten disease
11 August 2020 - Theranexus, a biopharmaceutical company innovating in the treatment of neurological diseases, and Beyond Batten Disease Foundation ...
Posted by Michael Wonder on 11 Aug 2020
Trump’s call for essential drugs to be made in US threatens innovation, says trade group
11 August 2020 - The trade group for the US pharmaceutical industry has warned that President Donald Trump’s latest executive ...
Posted by Michael Wonder on 11 Aug 2020
Mersana Therapeutics receives FDA fast track designation for XMT-1536 for the treatment of patients with platinum-resistant ovarian cancer
11 August 2020 - Mersana Therapeutics today announced that the U.S. FDA has granted fast track designation for XMT-1536, for the ...
Posted by Michael Wonder on 11 Aug 2020
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce U.S. FDA acceptance of biologics license application for pegunigalsidase alfa for the proposed treatment of Fabry disease and grants priority review
11 August 2020 - Protalix BioTherapeutics together with its development and commercialization partner Chiesi Global Rare Diseases, a unit of Chiesi, ...
Posted by Michael Wonder on 11 Aug 2020
Fennec Pharmaceuticals receives complete response letter from the FDA for its new drug application for Pedmark to prevent ototoxicity associated with cisplatin in paediatric patients with localised, non-metastatic, solid tumours
11 August 2020 - FDA pre-approval inspection has identified deficiencies with the facility of the drug product manufacturer, which require resolution ...
Posted by Michael Wonder on 11 Aug 2020
FDA head pledges 'we will not cut corners' on coronavirus vaccine
10 August 2020 - The head of the FDA pledged Monday that the U.S. "will not cut corners" in its ...
Posted by Michael Wonder on 10 Aug 2020
Gilead submits new drug application to U.S. Food and Drug Administration for Veklury (remdesivir) for the treatment of COVID-19
10 August 2020 - Veklury is currently available in the U.S. for the treatment of severe COVID-19 under an Emergency Use ...
Posted by Michael Wonder on 10 Aug 2020
Aquestive Therapeutics receives FDA fast track designation for AQST-108 (sublingual film formulation delivering systemic epinephrine) for treatment of allergic reactions including anaphylaxis
10 August 2020 - Finalising preparations for pharmacokinetic clinical trials of AQST-108. ...