Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Mar 2021
Kadmon announces U.S. FDA has extended the review period for belumosudil in chronic graft versus host disease
10 March 2021 - Kadmon today announced that the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 10 Mar 2021
AVEO Oncology announces U.S. FDA approval of Fotivda (tivozanib) for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma
10 March 2021 - AVEO plans to make Fotivda available to patients in the U.S. by 31 March 2021. ...
Posted by Michael Wonder on 10 Mar 2021
Vertex announces FDA fast track designation and initiation of a Phase 1/2 clinical trial for VX-880, a novel investigational cell therapy for the treatment of type 1 diabetes
10 March 2021 - VX-880 is the first investigational stem cell derived therapy utilising fully differentiated, insulin-producing pancreatic islet cells for ...
Posted by Michael Wonder on 10 Mar 2021
FDA accepts the new drug application for review of Idorsia’s daridorexant for the treatment of adult patients with insomnia
10 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant on ...