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RSS FeedPosted 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
EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events
15 March 2021 - Several authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination with COVID-19 Vaccine ...
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 14 Mar 2021
Approval of updated storage conditions for the Pfizer COVID-19 vaccine
13 March 2021 - The TGA has received and assessed additional data submitted by Pfizer for their COVID-19 vaccine (COMIRNATY - ...
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 13 Mar 2021
COVID-19 vaccines - safety and effectiveness in older adults
10 March 2021 - Data on real-world use of COVID-19 vaccines approved in Australia provides reassurance about their safety in ...
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. ...
Posted by Michael Wonder on 11 Mar 2021
COVID-19 vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine’s benefits currently still outweigh risks
11 March 2021 - The EMA is aware that the Danish Health Authority has paused its vaccination campaign with COVID-19 ...
Posted by Michael Wonder on 11 Mar 2021
Berlin Heals receives breakthrough device designation from FDA for its C-MIC heart failure device and initiates early feasibility study in the United States
11 March 2021 - Berlin Heals announced today that the US FDA has granted a breakthrough device designation for its ...
Posted by Michael Wonder on 11 Mar 2021
Denali Therapeutics announces fast track designation granted by the U.S. FDA to ETV:IDS (DNL310) for the treatment of patients with Hunter syndrome
11 March 2021 - Denali Therapeutics today announced that the U.S. FDA has granted fast track designation to ETV:IDS (DNL310) for ...
Posted by Michael Wonder on 11 Mar 2021
EMA recommends COVID-19 vaccine Janssen for authorisation in the EU
11 March 2021 - EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants fast track designation to Spectrum Pharmaceuticals’ poziotinib
11 March 2021 - Spectrum Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for poziotinib for the ...
Posted by Michael Wonder on 11 Mar 2021
EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19
11 March 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab which are ...
Posted by Michael Wonder on 11 Mar 2021
FDA grants breakthrough device designation for Inivata’s RaDaR assay
9 March 2021 - Designation will help accelerate the regulatory path of RaDaR for use in detection of minimal residual ...