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RSS FeedPosted by Michael Wonder on 26 Sep 2021
Australia secures supply of drug that treats arthritis and Covid
25 September 2021 - Health Minister Greg Hunt has secured an extra supply of a rheumatoid arthritis drug to treat critically ...
Posted by Michael Wonder on 26 Sep 2021
FDA tweaks biosimilar application review program
25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. ...
Posted by Michael Wonder on 25 Sep 2021
CARISMA Therapeutics announces U.S. FDA grants fast track designation to CT-0508 for the treatment of patients with solid tumours
22 September 2021 - CARISMA Therapeutics announced today that that the U.S. FDA has granted fast track designation to CT-0508, ...
Posted by Michael Wonder on 25 Sep 2021
FDA approves Repatha (evolocumab) in paediatric patients age 10 and older with heterozygous familial hypercholesterolaemia
24 August 2021 - Approval based on HAUSER RCT demonstrating a significant reduction in low-density lipoprotein cholesterol. ...
Posted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...
Posted by Michael Wonder on 25 Sep 2021
Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...
Posted by Michael Wonder on 24 Sep 2021
ATAGI update following weekly COVID-19 meeting (22 September 2021)
24 September 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 22 September ...
Posted by Michael Wonder on 24 Sep 2021
EU drugs regulator to decide on Pfizer vaccine booster in early October
23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...
Posted by Michael Wonder on 24 Sep 2021
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted fast track designation by the US FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma
22 September 2021 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a fast track ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...
Posted by Michael Wonder on 23 Sep 2021
ATAGI statement about the need for additional doses of COVID-19 vaccines
23 September 2021 - A statement from the Australian Technical Advisory Group on Immunisation about the need for COVID-19 vaccine booster ...
Posted by Michael Wonder on 23 Sep 2021
FDA authorises booster dose of Pfizer-BioNTech COVID-19 vaccine for certain populations
22 September 2021 - Today, the U.S. FDA amended the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine to allow ...
Posted by Michael Wonder on 23 Sep 2021
COVID-19 vaccine weekly safety report (23 September 2021)
23 September 2021 - To 19 September 2021, approximately 24.8 million vaccine doses have been given in Australia – 15.1 million ...
Posted by Michael Wonder on 22 Sep 2021
Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada
22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...
Posted by Michael Wonder on 22 Sep 2021
FDA approves ruxolitinib for chronic graft-versus-host disease
22 September 2021 - Today the Food and Drug Administration approved ruxolitinib (Jakafi, Incyte) for chronic graft-versus-host disease after failure ...