Blog
RSS FeedPosted by Michael Wonder on 22 Mar 2022
Prescription medicines: new or extended uses, or new combinations of registered medicines (February 2022)
22 March 2022 - The TGA approved a new indication for 7 medicines and one vaccine in February. ...
Posted by Michael Wonder on 22 Mar 2022
Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator
21 March 2022 - In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has ...
Posted by Michael Wonder on 22 Mar 2022
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted rare paediatric disease designation by the US FDA for the treatment of neuroblastoma
21 March 2022 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor, alrizomadlin (APG-115), was granted a rare paediatric disease ...
Posted by Michael Wonder on 22 Mar 2022
KYE Pharmaceuticals files Accrufer new drug submission in Canada for the treatment of iron deficiency
21 March 2022 - Shield Therapeutics announces that KYE Pharmaceuticals has submitted a new drug submission to Health Canada for ...
Posted by Michael Wonder on 22 Mar 2022
Travere Therapeutics submits new drug application for sparsentan for the treatment of IgA nephropathy
21 March 2022 - Travere Therapeutics today announced that it has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 22 Mar 2022
Prescription medicines: applications under evaluation (March 2022)
22 March 2022 - The TGA has updated its list of applications for new medicines or new uses for existing ...
Posted by Michael Wonder on 21 Mar 2022
FDA approves pembrolizumab for advanced endometrial carcinoma
21 March 2022 - Today, the FDA approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial ...
Posted by Michael Wonder on 21 Mar 2022
Provention Bio announces FDA acceptance of the biologics license application resubmission for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals
21 March 2022 - FDA Sets Goal Date of August 17, 2022. ...
Posted by Michael Wonder on 21 Mar 2022
EMA publishes agenda for 21-24 March CHMP meeting
21 March 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Mar 2022
ATAGI update following weekly COVID-19 meeting (16 March 2022)
21 March 2022 - An update from the Australian Technical Advisory Group on Immunisation (ATAGI) following their weekly meeting on 16 ...
Posted by Michael Wonder on 20 Mar 2022
AbbVie expands immunology portfolio in Canada as Health Canada approves Skyrizi (risankizumab) for the treatment of adults with active psoriatic arthritis
17 March 2022 - Approval supported by data from two Phase 3 studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 ...
Posted by Michael Wonder on 20 Mar 2022
U.S. Food and Drug Administration approves first LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab-rmbw), as treatment for patients with unresectable or metastatic melanoma
18 March 2022 - Opdualag is a first in class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and ...
Posted by Michael Wonder on 19 Mar 2022
Heron Therapeutics announces approval of Zynrelef by Health Canada for the management of post-operative pain
17 March 2022 - ZYNRELEF is the first and only extended-release local anaesthetic approved by Health Canada. ...
Posted by Michael Wonder on 18 Mar 2022
Moderna submits amendment to the emergency use authorisation for an additional booster dose of its COVID-19 vaccine in the U.S.
17 March 2022 - Moderna today announced that it has submitted a request to the U.S. FDA for an amendment ...
Posted by Michael Wonder on 18 Mar 2022
Marinus Pharmaceuticals announces FDA approval of Ztalmy (ganaxolone) for CDKL5 deficiency disorder
18 March 2022 - Rare paediatric disease priority review voucher awarded to Marinus Pharmaceuticals by the FDA. ...