Blog
RSS FeedPosted by Michael Wonder on 07 Mar 2022
Jardiance (empagliflozin) becomes the first and only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction
7 March 2022 - The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with ...
Posted by Michael Wonder on 07 Mar 2022
ATAGI update following weekly COVID-19 meeting (2 March 2022)
7 March 2022 - As of 1 March 2022, over 54 million doses of COVID-19 vaccines have been administered in ...
Posted by Michael Wonder on 06 Mar 2022
Australian COVID nasal spray not on shop shelves amid TGA dispute
4 March 2022 - Melbourne start-up Starpharma is at loggerheads with the medicines regulator over the approvals process for its ...
Posted by Michael Wonder on 06 Mar 2022
U.S. Food and Drug Administration approves Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for certain adult patients with resectable non-small cell lung cancer
4 March 2022 - Approval marks the first and only immunotherapy-based treatment for use before surgery for non-small cell lung cancer. ...
Posted by Michael Wonder on 04 Mar 2022
Nymox announces submission of new drug application to the FDA for fexapotide triflutate
3 March 2022 - Nymox Pharmaceutical Corporation is pleased to announce today that it has submitted the Company’s new drug application ...
Posted by Michael Wonder on 04 Mar 2022
BeiGene announces Health Canada approval for Brukinsa (zanubrutinib) in relapsed or refractory marginal zone lymphoma
3 March 2022 - Third approved indication for Brukinsa in Canada, following mantle cell lymphoma and Waldenström’s macroglobulinaemia. ...
Posted by Michael Wonder on 04 Mar 2022
Science hasn’t shown these medications work. They’re being sold anyway.
3 March 2022 - Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk ...
Posted by Michael Wonder on 04 Mar 2022
Approved first generic for Apokyn injection cartridges requires separately packaged pen
24 February 2022 - The U.S. FDA has approved the first generic of Apokyn (apomorphine hydrochloride injection) drug cartridges to ...
Posted by Michael Wonder on 03 Mar 2022
U.S. Food and Drug Administration grants Cabaletta Bio fast track designation for MuSK-CAART
1 March 2022 - Fast Track Designation granted to improve activities of daily living and muscle strength in patients with ...
Posted by Michael Wonder on 03 Mar 2022
Medicines Australia welcomes reform efforts to speed up clinical trials
4 March 2022 - Australian patients will have improved access to clinical trials due to reforms to be introduced by ...
Posted by Michael Wonder on 03 Mar 2022
TG Therapeutics announces extension of U.S. FDA BLA/sNDA PDUFA date for ublituximab plus Ukoniq to treat patients with CLL and SLL
3 March 2022 - FDA sets updated PDUFA goal date of June 25, 2022. ...
Posted by Michael Wonder on 03 Mar 2022
PRIME enables earlier availability of life-changing medicines
3 March 2022 - EMA’s PRIority Medicines (PRIME) scheme has had a positive impact on the authorisation of new medicines that ...
Posted by Michael Wonder on 03 Mar 2022
Digital Therapeutics should be regulated with gold standard evidence
28 February 2022 - There is enormous growth in the digital health sector, illustrated by huge capital investment, and a massive ...
Posted by Michael Wonder on 03 Mar 2022
AltPep receives FDA breakthrough device designation for SOBA-AD, a simple blood test for the detection of Alzheimer’s disease
1 March 2022 - AltPep Corporation today announced the U.S. FDA granted the company breakthrough device designation for its SOBA-AD diagnostic ...
Posted by Michael Wonder on 03 Mar 2022
Harpoon Therapeutics receives FDA fast track designation for HPN217
2 March 2022 - Harpoon Therapeutics today announced that the U.S. FDA has granted fast track designation to HPN217, a BCMA ...