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RSS FeedPosted by Michael Wonder on 30 Oct 2020
How will a COVID vaccine be distributed once it's approved by FDA?
29 October 2020 - Distributing the first wave of doses will be a massive undertaking. ...
Posted by Michael Wonder on 29 Oct 2020
The FDA will not inspect vaccine production plants
29 October 2020 - Approval of a vaccine by the FDA typically requires inspection of the vaccine’s manufacturing plants. ...
Posted by Michael Wonder on 29 Oct 2020
Roche receives FDA approval for the cobas EGFR Mutation Test v2 as the first companion diagnostic test for expanded EGFR TKI therapies in patients with non-small cell lung cancer
29 October 2020 - The new FDA approval allows the test to be used as a companion diagnostic for a broad ...
Posted by Michael Wonder on 29 Oct 2020
FDA accepts for priority review Libtayo (cemiplimab-rwlc) for advanced non-small cell lung cancer with PD-L1 expression of ≥50%
29 October 2020 - Regeneron Pharmaceuticals today announced that the U.S. FDA has accepted for priority review the supplemental biologics license ...
Posted by Michael Wonder on 29 Oct 2020
reVision Therapeutics announces US FDA grant of rare paediatric disease and orphan drug designation for REV-0100 for the treatment of Stargardt disease
28 October 2020 - reVision Therapeutics today announced that the US FDA has granted the Company's request to designate REV-0100 as ...
Posted by Michael Wonder on 29 Oct 2020
Passage Bio’s PBKR03 receives orphan drug and rare paediatric disease designations from FDA for treatment of Krabbe disease
28 October 2020 - Passage Bio today announced that the U.S. FDA has granted orphan drug and rare paediatric disease designations ...
Posted by Michael Wonder on 28 Oct 2020
Astellas receives U.S. FDA fast track designation for ASP5354, an investigational near-infrared fluorescence imaging agent
28 October 2020 - Astellas Pharma announced today that the US FDA has granted fast track designation based on non-clinical and ...
Posted by Michael Wonder on 28 Oct 2020
Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralising antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19
28 October 2020 - Initial agreement for 300,000 vials with potential for purchase of an additional 650,000 vials. ...
Posted by Michael Wonder on 28 Oct 2020
Enhertu granted priority review in the US for the treatment of HER2 positive metastatic gastric cancer
28 October 2020 - Only HER2 directed medicine to demonstrate significant improvement in overall survival compared to chemotherapy for previously ...
Posted by Michael Wonder on 28 Oct 2020
Taysha Gene Therapies receives rare paediatric disease designation and orphan drug designation for TSHA-104 to treat SURF1 associated Leigh syndrome
27 October 2020 - Taysha anticipated to submit Investigational new drug application for TSHA-104 to FDA in 2021. ...
Posted by Michael Wonder on 27 Oct 2020
FDA approves lotion for non-prescription use to treat head lice
27 October 2020 - Today, the U.S. FDA approved a lotion to treat head lice for nonprescription, or over-the-counter (OTC), use ...
Posted by Michael Wonder on 27 Oct 2020
COVID-19 vaccine rollout calls for supply chain collaboration, logistics chief says
26 October 2020 - Kuehne + Nagel CEO Detlef Trefzger says rush will be manageable despite strains on transportation capacity. ...
Posted by Michael Wonder on 27 Oct 2020
Dracen Pharmaceutical’s DRP-104 granted U.S. FDA fast track designation for the treatment of non-small cell lung cancer
27 October 2020 - Dracen to work closely with FDA to advance the clinical program for the treatment of non-small cell ...
Posted by Michael Wonder on 27 Oct 2020
Kala Pharmaceuticals announces FDA approval of Eysuvis for the short-term treatment of the signs and symptoms of dry eye disease
27 October 2020 - First approved prescription therapy specifically for short-term treatment of dry eye disease. ...
Posted by Michael Wonder on 27 Oct 2020
FDA approves new FoundationOne Liquid CDx companion diagnostic indications for three targeted therapies that treat advanced ovarian, breast and non-small cell lung cancer
27 October 2020 - Foundation Medicine today announced that the U.S. FDA approved FoundationOne Liquid CDx for three new companion ...