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RSS FeedPosted by Michael Wonder on 18 Mar 2021
Celularity announces fast track designation by the FDA for its natural killer cell therapy CYNK-001 in the treatment of recurrent glioblastoma multiforme
18 March 2021 - Celularity announced that the company has received fast track designation from the U.S. FDA for its non-genetically ...
Posted by Michael Wonder on 17 Mar 2021
FDA permits marketing of first SARS-CoV-2 diagnostic test using traditional premarket review process
17 March 2021 - BioFire Respiratory Panel 2.1 is the first COVID-19 diagnostic test granted marketing authorisation using the de novo ...
Posted by Michael Wonder on 17 Mar 2021
Sagimet Biosciences receives fast track designation from U.S. FDA for FASN inhibitor TVB-2640 in NASH
16 March 2021 - Sagimet Biosciences announced today that the U.S. FDA has granted fast track designation to TVB-2640 for ...
Posted by Michael Wonder on 17 Mar 2021
U.S. plans to use real world and trial data to determine when vaccines need to be updated
17 March 2021 - U.S. officials plan to use data gathered from people who have already been vaccinated against COVID-19 as ...
Posted by Michael Wonder on 17 Mar 2021
AbbVie announces extension of review for supplemental new drug application of upadacitinib for the treatment of adults with active psoriatic arthritis
17 March 2021 - AbbVie announced that the U.S. FDA has extended the review period for the supplemental new drug application ...
Posted by Michael Wonder on 17 Mar 2021
Sparta Biomedical receives FDA breakthrough device designation for SBM-01 biomimetic implant
17 March 2021 - Sparta Biomedical today announced that its SBM-01 biomimetic implant has been granted a breakthrough device designation from ...
Posted by Michael Wonder on 17 Mar 2021
Leveraging real world evidence in regulatory submissions of medical devices
16 March 2021 - Among the many ways that the U.S. FDA protects and promotes the public health is by ensuring ...
Posted by Michael Wonder on 16 Mar 2021
Merck receives priority review from FDA for new drug application for HIF-2α inhibitor belzutifan (MK-6482)
16 March 2021 - Application based on objective response rate from Phase 2 trial evaluating belzutifan in patients with von Hippel-Lindau ...
Posted by Michael Wonder on 15 Mar 2021
Confirmation of Technigas US FDA timetable
12 March 2021 - Cyclopharm has provided an update of the US FDA’s timetable in respect of approval of the Company’s ...
Posted by Michael Wonder on 15 Mar 2021
Melinta Therapeutics announces FDA approval of Kimyrsa (ortivancin) for the treatment of adult patients with acute bacterial skin and skin structure infections
15 March 2021 - Single dose antibiotic with one hour infusion, additional compatibilities in normal saline and D5W, and lower infusion ...
Posted by Michael Wonder on 15 Mar 2021
PharmaEssentia provides U.S. regulatory update on ropeginterferon alfa-2b-njft for the treatment of polycythemia vera
14 March 2021 - PharmaEssentia Corporation today announced that the U.S. FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 15 Mar 2021
BioXcel Therapeutics receives FDA breakthrough therapy designation for BXCL501 for the acute treatment of agitation associated with dementia
15 March 2021 - Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options ...
Posted by Michael Wonder on 15 Mar 2021
Calliditas announces submission of new drug application to U.S. FDA for Nefecon in patients with primary IgA nephropathy
15 March 2021 - Calliditas Therapeutics today announced the submission of a new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 13 Mar 2021
Marius Pharmaceuticals receives PDUFA date for Kyzatrex NDA for treatment of hypogonadism
11 March 2021 - Marius Pharmaceuticals announced today that the U.S. FDA has assigned a Prescription Drug User Fee Act goal ...
Posted by Michael Wonder on 11 Mar 2021
Revolutionary option for medical device sterilisation approved by FDA
11 March 2021 - The United States FDA newly approved chlorine dioxide gas for contract sterilisation of medical devices. ...