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RSS FeedPosted by Michael Wonder on 03 Nov 2021
TransThera receives fast track designation from FDA for its core product TT-00420 to treat cholangiocarcinoma
3 November 2021 - TransThera Sciences announced that the U.S. FDA has granted fast track designation to its phase II ...
Posted by Michael Wonder on 03 Nov 2021
AvroBio receives rare paediatric disease designation from the U.S. FDA for AVR-RD-05, a gene therapy for mucopolysaccharidosis type II or Hunter syndrome
3 November 2021 - AVROBIO today announced that the U.S. FDA has granted rare paediatric disease designation to AVR-RD-05, its ...
Posted by Michael Wonder on 03 Nov 2021
Allena Pharmaceuticals receives fast track designation from FDA for the development of ALLN-346 for chronic treatment of hyperuricemia in patients with gout and advanced chronic kidney disease
3 November 2021 - Novel oral therapeutic candidate ALLN-346 targets uric acid in the intestinal tract. ...
Posted by Michael Wonder on 03 Nov 2021
Opdivo receives two new Health Canada approvals
2 November 2021 - Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for Opdivo (nivolumab). ...
Posted by Michael Wonder on 03 Nov 2021
Health Canada issues Notice of Compliance for Jardiance (empagliflozin) for the treatment of heart failure with reduced ejection fraction
2 November 2021 - This new indication is based on the EMPEROR-Reduced trial, which showed a significant 25% reduction in the ...
Posted by Michael Wonder on 03 Nov 2021
Amylyx Pharmaceuticals submits new drug application for AMX0035 for the treatment of ALS
2 November 2021 - Amylyx Pharmaceuticals today announced it has submitted a new drug application to the U.S. FDA for AMX0035 ...
Posted by Michael Wonder on 02 Nov 2021
FDA grants breakthrough status for Alzheimer's treatment
2 November 2021 - Renew Bioscience announced it has received breakthrough device designation status from the U.S. FDA for the ...
Posted by Michael Wonder on 02 Nov 2021
I’ve worked with Robert Califf. He is the leader the FDA needs.
2 November 2021 - If the cascade of news reports are true, President Biden is finally about to name his choice ...
Posted by Michael Wonder on 02 Nov 2021
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
2 November 2021 - EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of ...
Posted by Michael Wonder on 02 Nov 2021
Otsuka submits initial marketing authorization application to the European Medicines Agency for vadadustat for the treatment of adults with anemia associated with chronic kidney disease
29 October 2021 - Otsuka announces that Otsuka Pharmaceutical Netherlands has submitted an initial marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
Posted by Michael Wonder on 02 Nov 2021
Moderna provides update on timing of U.S. emergency use authorisation of its COVID-19 vaccine for adolescents
31 October 2021 - Moderna today provided an update that the U.S. FDA has notified the Company that it will ...
Posted by Michael Wonder on 02 Nov 2021
Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma
1 November 2021 - FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022. ...
Posted by Michael Wonder on 02 Nov 2021
ANI Pharmaceuticals announces FDA approval of purified cortrophin gel for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome
1 November 2021 - Approval re-introduces much needed patient and physician choice into the U.S. repository corticotropin market. ...
Posted by Michael Wonder on 02 Nov 2021
Janssen announces extension of U.S. FDA BLA PDUFA date for BCMA CAR-T ciltacabtagene autoleucel
1 November 2021 - Janssen announced today the U.S. FDA has extended the Prescription Drug User Fee Act date to ...