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RSS FeedPosted by Michael Wonder on 25 Feb 2021
Dascena announces FDA breakthrough device designation granted to machine learning diagnostic method
24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...
Posted by Michael Wonder on 25 Feb 2021
Kura Oncology receives FDA breakthrough therapy designation for tipifarnib in head and neck squamous cell carcinoma
24 February 2021 - Kura Oncology today announced that its investigational drug, tipifarnib, has been granted breakthrough therapy designation by the ...
Posted by Michael Wonder on 24 Feb 2021
Biden to sign order seeking homegrown fixes for shortfalls of foreign-made items
24 February 2021 - Shortages of medical supplies and ingredients for pharmaceuticals came into stark focus during the early days ...
Posted by Michael Wonder on 24 Feb 2021
ViiV Healthcare submits supplemental new drug application to US FDA for expanded use of Cabenuva (cabotegravir, rilpivirine) as an HIV treatment for use every 2 months
24 February 2021 - ViiV Healthcare announced today the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 24 Feb 2021
Locate Bio’s Chondro3 granted FDA breakthrough device designation
24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...
Posted by Michael Wonder on 24 Feb 2021
U.S. FDA accepts for priority review Pfizer's application for Ticovac (tick-borne encephalitis vaccine)
23 February 2021 - If approved, the vaccine may help reduce the risk of tick-borne encephalitis for people traveling to endemic ...
Posted by Michael Wonder on 24 Feb 2021
Inovise receives breakthrough device designation for novel non-invasive system to remotely monitor risk of decompensation in heart failure patients
23 February 2021 - Inovise Medical today announced the U.S. FDA has granted breakthrough device designation for its Audicor heart failure ...
Posted by Michael Wonder on 23 Feb 2021
FDA approves EndoClot Hemostat to manage GI bleeding
23 February 2021 - A unique product to rapidly and reliably control bleeding during GI procedures. ...
Posted by Michael Wonder on 23 Feb 2021
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures
24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...
Posted by Michael Wonder on 23 Feb 2021
Amgen submits supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
22 February 2021 - Filing based on data from Phase 3 ADVANCE trial. ...
Posted by Michael Wonder on 22 Feb 2021
Piccolo Medical receives U.S. FDA clearance of its SmartPICC system for the positioning of peripherally inserted central catheters
22 February 2021 - Piccolo Medical announces that it has received FDA clearance of its SmartPICC System. ...
Posted by Michael Wonder on 22 Feb 2021
Intra-Cellular Therapies applies for FDA approval of Caplyta (lumateperone) for the treatment of bipolar depression
22 February 2021 - If approved, Caplyta has the potential to treat the broadest range of patients with bipolar depression. ...
Posted by Michael Wonder on 22 Feb 2021
Supernus receives FDA notice assigning early April 2021 PDUFA date for SPN-812 NDA
22 February 2021 - Supernus Pharmaceuticals today announced that it received notice from the U.S. FDA that the company’s new drug ...
Posted by Michael Wonder on 22 Feb 2021
Celsion Corporation receives FDA fast track designation for GEN-1 in advanced ovarian cancer
22 February 2021 - Designation provides potential for an expedited regulatory review.. ...
Posted by Michael Wonder on 22 Feb 2021
FDA outlines fast path for shots against new virus variants
23 February 2021 - Variants are already causing problems for testing, treatment. ...